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Appendix A
File No. 29/Misc./03/2020-DC (182)
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
Notice
Classification of Medical Devices Pertaining to Gastroenterology
Sr Risk
Medical Device Name Intended Use
No. Class
To be placed over a continent enteric stoma
(surgically-created artificial opening between the
intestines and the body surface through which bodily
Absorbent enteric stomal
1 waste is drained from the intestines) to protect it B
dressing
from harmful external influences, which includes
absorbent materials intended to protect the
surrounding skin from enteric fluids.
To be intended for the circumferential resection of
2 Anal fistula circular cutter B
tissue to treat simple anal fistula
A sterile implantable cord intended to be placed
through an anal fistula tract and tied outside the
3 Anal fistula seton C
fistula, forming a loop around the anus, to allow
drainage through the fistula for tissue healing.
An endoscope with a rigid inserted portion intended
4 Anoscope, reusable for the visual examination and treatment of the anus B
and rectum.
A sterile endoscope with a rigid inserted portion
5 Anoscope, single-use intended for the visual examination and treatment of B
the anus and rectum.
A flexible tube designed to administer barium, a
contrast medium, into the lower gastrointestinal tract
6 Barium enema catheter B
by way of the rectum, for radiographic visualization
of the area.
An implantable artificial substitute for the tube-like
7 Bile duct prosthesis structure that carries bile from the gallbladder to the C
duodenum.
A sterile, non-electrical flexible tube intended to be
Biliary manometric inserted into the biliary tree to measure pressures
8 B
catheter within the ducts, especially to evaluate sphincter of
Oddi function.
Page 1 of 17A sterile device designed to manually inflate and
regulate the pressure of a balloon catheter (e.g., by
injecting and aspirating fluid or air within the
Catheter-balloon inflator,
9 balloon), and to deflate the balloon during a medical B
reprocessed
procedure.It is typically used during angiography,
angioplasty, gastrointestinal (GI), or sinuplasty
procedures.
A device designed to manually inflate and regulate
Catheter-balloon inflator, the pressure of a balloon catheter (e.g., by injecting
10 B
reusable and aspirating fluid or air within the balloon), and to
deflate the balloon during a medical procedure.
A sterile device designed to manually inflate and
regulate the pressure of a balloon catheter (e.g., by
Catheter-balloon inflator,
11 injecting and aspirating fluid or air within the B
single-use
balloon), and to deflate the balloon during a medical
procedure.
A flexible tube inserted through a flexible
endoscope, after its placement in the duodenum via
the oral cavity, for the endoscopic cannulation of the
Cholangiopancreatography
12 gastrointestinal ductal system (i.e., the pancreatic, B
catheter, reusable
hepatic, and/or common bile ducts) during
endoscopic retrograde cholangiopancreatography
(ERCP).
A flexible tube inserted through a flexible
endoscope, after its placement in the duodenum via
the oral cavity, intended for the endoscopic
Cholangiopancreatography
13 cannulation of the gastrointestinal ductal system B
catheter, single-use
(i.e., the pancreatic, hepatic, and/or common bile
ducts) during endoscopic retrograde
cholangiopancreatography (ERCP).
A non-sterile plastic pouch designed to be attached
Closed-ended intestinal around a faecal stoma for use as a receptacle for
14 A
ostomy bag, multiple-piece faeces following a colostomy [the stool (faeces)
being generally well formed].
A non-sterile plastic pouch designed to be attached
with an adhesive to the skin around a faecal stoma
Closed-ended intestinal
15 and used as a receptacle for faeces following a A
ostomy bag, one-piece
colostomy [the stool (faeces) being generally well
formed].
A sterile distal attachment to a flexible endoscope
16 Colonic endoscopy cuff intended to improve endoscopic control and bowel B
visualization during colonic endoscopy.
A collection of sterile devices intended to be used
during open colorectal surgery (bowel resection) to
irrigate the colon above (proximal to) the site of a
17 Colonic lavage kit, surgical B
lesion/blockage, prior to surgical anastomosis, when
preoperative preparation of the colon has not been
possible, normally due to obstruction.
Page 2 of 17A non-sterile solution/suspension intended to be
introduced into the sigmoid/descending colon as an
enema for the treatment of inflammatory bowel
Colonic mucosa barrier
18 disease (e.g., ulcerative colitis). It is intended to C
dressing
create an adhesive physical barrier on the colonic
mucosa to protect the mucosa from potentially
harmful substances in the distal colon lumen
A non-sterile endoscopic sheath with two inflatable
Colonoscope positioning balloons designed to be mounted on a colonoscope
19 B
sleeve to position and stabilize the endoscope within the
large intestine of a patient.
A dedicated stiff wire that is inserted into a flexible
colonoscope to allow the physician to increase the
20 Colonoscope stiffener B
stiffness of the colonoscope when extra rigidity is
required during a colonoscopy.
A hand-held manual surgical instrument designed to
assess colon and/or rectal lumen diameter to aid the
21 Colorectal sizer selection of an appropriate size intraluminal stapler B
(i. e, the stapler head) for bowel anastomosis
following transection.
A hand-held manual surgical instrument designed to
22 Common bile duct dilator dilate the common bile duct, i.e., the union of the B
cystic and hepatic ducts.
A non-sterile stent-like device with a valve designed
to be implanted in the duodenum where it is
23 Duodenal bypass liner C
intended to reduce duodenal nutrient absorption
from food to facilitate obese patient weight loss.
A sterile stent-like implant designed to function as
an impermeable barrier in the duodenum and part of
the jejunum for partially-digested food from the
Duodenal-jejunal bypass
24 stomach (chyme) passing on its inside and C
liner
bile/digestive enzymes passing on its outside,
intended to treat type 2 diabetes mellitus and
obesity.
A sterile plastic tube designed to be placed onto the
distal end of an endoscope (e.g., oesophagoscope)
Endoscope tissue removal
25 to facilitate the removal of coagulated blood/tissue B
cap
during electrosurgical treatment (e.g., for the
treatment of Barrett’s oesophagus).
A non-sterile device intended to be fitted to an
endoscope biopsy port to enable access
Endoscopic biopsy valve,
26 for/exchange of endoscopic devices while A
non-sterile
maintaining insufflation and minimizing leakage of
biomaterial during an endoscopic procedure.
A sterile device intended to be fitted to an
endoscope biopsy port to enable access
Endoscopic biopsy valve,
27 for/exchange of endoscopic devices while B
sterile
maintaining insufflation and minimizing leakage of
biomaterial during an endoscopic procedure.
Page 3 of 17A rod-like component of an endoscopic cutting
Endoscopic cutting stapler
28 stapler intended to enable connection between the B
connector
stapler handpiece and the endpiece/loading unit.
A collection of sterile devices, which includes an
Endoscopic electrosurgical implantable haemostatic ligation clip, intended to be
29 biopsy/resection kit, full- used to obtain a full-thickness tissue biopsy and/or C
thickness therapeutic resection of gastric, duodenal, colonic,
and/or rectal tissue during an endoscopic procedure.
A collection of devices designed to be inserted
through a compatible endoscope to obtain a
Endoscopic electrosurgical
mucosal tissue biopsy and/or therapeutic resection
30 biopsy/resection kit, C
of upper gastrointestinal (GI) tract tissue, typically
partial-thickness
during endoscopic retrograde
cholangiopancreatography (ERCP) procedures.
A sterile, invasive, endoscopic device intended to
Endoscopic electrosurgical deliver both: 1) a submucosal lifting solution; and 2)
31 electrode/submucosal lift an electrosurgical current in a monopolar B
needle configuration (i.e., with a return electrode) to tissues
for cutting/coagulation.
A sterile invasive device intended to be used to
Endoscopic dilate or expand a narrowing lesion (e.g.,
32 gastrointestinal stenosis oesophageal stricture, stenosis) in the lumen of the B
dilator gastrointestinal [GI] tract, under endoscopic
visualization.
A hand-held, battery-powered surgical instrument
designed to be used during endoscopic surgical
Endoscopic motorized
33 procedures for the expeditious transection and B
cutting stapler, reusable
resection of tissues and the creation of
anastomoses.
A sterile, hand-held, battery-powered surgical
instrument designed to be used during endoscopic
Endoscopic motorized
34 surgical procedures for the expeditious transection B
cutting stapler, single-use
and resection of tissues and the creation of
anastomoses.
A sterile, flexible tube intended to non-invasively
deliver a submucosal lifting solution into the
Endoscopic needleless submucosa of the gastrointestinal tract through a
35 B
submucosal lift catheter flexible endoscope during an endoscopic procedure
(e.g., gastroscopy, colonoscopy) to lift a lesion,
typically for subsequent excision.
A tubular device intended to be used in combination
with a compatible flexible endoscope to aid in
Endoscopic overtube, endoscopic insertions and to secure a pathway for
36 B
reusable multiple endoscopic intubations during diagnostic
and therapeutic endoscopic procedures (e.g., upper
and/or lower gastrointestinal (GI) tract endoscopy).
A sterile, flexible tube intended to be used with an
37 Endoscopic spray catheter endoscope (e.g., colonoscope) to administer fluids B
(e.g., dyes for mucosal coloration) in spray form.
Page 4 of 17A non-sterile device made with Hevea natural rubber
latex (NRL) intended to be connected to an enema
38 Enema tip, reusable A
tube to facilitate delivery of an enema solution into
the rectum.
A non-sterile, length of tubing that is used as a
conduit between the enema bag and the enema tip
39 Enema tube A
for the delivery of the enema solution into the
rectum.
A collection of non-sterile compounds and devices
intended to be used to prevent and/or remove,
Enteral feeding tube
40 through biochemical action, an enteral formula clog B
clearing kit
in an in situ enteral feeding tube to maintain luminal
patency.
A non-sterile, sheath-covered device intended to be
Enteral used to mechanically clear a clog in an in situ
41 feeding/decompression nasogastric, nasoenteral, gastrostomy and/or A
tube clearing stem jejunostomy tube, used for feeding and/or
decompression, to maintain luminal patency.
A non-sterile, thin, flexible tube intended for
extracorporeal connection to an enteral feeding tube
Enteral tube extension, (e.g., nasogastric tube) to increase the length of
42 B
non-sterile tubing from the patient to an oral/enteral device
(e.g., syringe) during enteral feeding/medication
administration or aspiration.
A sterile, thin, flexible tube intended for
extracorporeal connection to an enteral feeding tube
Enteral tube extension, (e.g., nasogastric tube) to increase the length of
43 B
sterile tubing from the patient to an oral/enteral device
(e.g., syringe) during enteral feeding/medication
administration or aspiration.
A non-sterile endoscope with a highly flexible sleeve
Externally-propelled and distal tip intended for the visual examination of
44 B
flexible video colonoscope the entire adult colon [lower gastrointestinal (GI)
tract].
A sterile, bioabsorbable, animal-derived substance
intended to be injected into a fistula tract (e.g., anal
Fistula-repair biomatrix
45 or rectal fistula) to close it by adding volume and D
implant
promoting the ingrowth and neovascularization of
host tissue.
An endoscope with a flexible inserted portion
Flexible fibreoptic intended for the visual examination and treatment of
46 B
choledochoscope the choledoc, better known as the common bile duct
(CBD).
An endoscope with a flexible inserted portion
Flexible fibreoptic
47 intended for the visual examination and treatment of B
colonoscope
the entire colon [lower gastrointestinal (GI) tract].
An endoscope with a flexible inserted portion
Flexible fibreoptic
48 intended for the visual examination and treatment of B
duodenoscope
the duodenum (the first part of the small intestine).
Page 5 of 17An endoscope with a flexible inserted portion
Flexible fibreoptic intended for the visual examination and treatment of
49 B
enteroscope the small intestine (the duodenum, jejunum, and
ileum).
An endoscope with a flexible inserted portion
intended for the visual examination and treatment of
Flexible fibreoptic
50 the upper gastrointestinal (GI) tract [oesophagus, B
gastroduodenoscope
stomach, and duodenum (the first part of the small
intestine), including the pancreas and the bile duct].
An endoscope with a flexible inserted portion
Flexible fibreoptic
51 intended for the visual examination and treatment of B
gastroscope
the oesophagus and the stomach.
An endoscope with a flexible inserted portion
Flexible fibreoptic
52 intended the visual examination and treatment of the B
oesophagoscope
oesophagus.
An endoscope with a flexible inserted portion
Flexible fibreoptic
53 intended for the visual examination and treatment in B
pancreatoscope
the pancreas.
An endoscope with a flexible inserted portion
Flexible fibreoptic intended for the visual examination and treatment of
54 B
sigmoidoscope the sigmoid colon (the distal S-shaped part of the
large intestine leading to the rectum).
An endoscope with a flexible inserted portion
Flexible ultrasound
55 intended for the visual examination and treatment of B
colonoscope
the entire colon [lower gastrointestinal (GI) tract].
An endoscope with a flexible inserted portion,
Flexible ultrasound combined with an ultrasound probe, intended for the
56 B
duodenoscope visual examination and treatment of the duodenum
(the first part of the small intestine).
An endoscope with a flexible inserted portion,
combined with an ultrasound probe, intended for the
Flexible ultrasound visual examination and treatment of the upper
57 B
gastroduodenoscope gastrointestinal (GI) tract [oesophagus, stomach,
and duodenum (the first part of the small intestine),
including the pancreas and the bile duct].
An endoscope with a flexible inserted portion
Flexible video intended for the visual examination and treatment of
58 B
choledochoscope the choledoc, better known as the common bile duct
(CBD).
An endoscope with a flexible inserted portion
Flexible video intended for the visual examination and treatment of
59 choledochoscope, single- the biliary tract and related ducts [e.g., common bile B
use duct (CBD), cystic duct, pancreatic duct], and for the
removal of gallstones.
An endoscope with a flexible inserted portion
Flexible video
60 intended for the visual examination and treatment of B
colonoscope, reusable
the entire colon [lower gastrointestinal (GI) tract].
Page 6 of 17A sterile endoscope with a flexible inserted portion
Flexible video
61 intended for the visual examination and treatment of B
colonoscope, single-use
the entire colon [lower gastrointestinal (GI) tract].
An endoscope with a flexible inserted portion
Flexible video
62 intended for the visual examination and treatment of B
duodenoscope, reusable
the duodenum (the first part of the small intestine).
An endoscope with a flexible inserted portion
Flexible video
63 intended for the visual examination and treatment of B
duodenoscope, single-use
the duodenum (the first part of the small intestine).
An endoscope with a flexible inserted portion
intended for the visual examination and treatment of
64 Flexible video enteroscope B
the small intestine (the duodenum, jejunum, and
ileum).
An endoscope with a flexible inserted portion
intended for the visual examination and treatment of
Flexible video
65 the upper gastrointestinal (GI) tract [oesophagus, B
gastroduodenoscope
stomach, and duodenum (the first part of the small
intestine), including the pancreas and the bile duct].
An endoscope with a flexible inserted portion
66 Flexible video gastroscope intended for the visual examination and treatment of B
the oesophagus and the stomach.
An endoscope with a flexible inserted portion
intended for the visual examination and treatment of
the oesophagus. It is inserted into the body through
the mouth. Anatomical images are obtained via a
Flexible video
67 camera incorporated at the distal end of the B
oesophagoscope, reusable
oesophagoscope and are shown on a monitor. This
device is commonly used to examine abnormalities
in the tissue structure and mucous lining of the
oesophagus. This is a reusable device.
Flexible video An endoscope with a flexible inserted portion
68 oesophagoscope, single- intended for the visual examination and treatment of B
use the oesophagus.
An endoscope with a flexible inserted portion
Flexible video
69 intended for the visual examination and treatment in B
pancreatoscope
the pancreas.
An endoscope with a flexible inserted portion
Flexible video intended for the visual examination and treatment of
70 B
sigmoidoscope the sigmoid colon (the distal S-shaped part of the
large intestine leading to the rectum).
A sterile implantable device intended to be wrapped
around the proximal portion of the stomach to
reduce stomach volume and facilitate weight loss in
71 Gastric sleeve C
overweight/obese patients by attempting to restrict
the quantity of food consumed through an increased
sense of satiety (fullness).
Page 7 of 17A sterile flexible tube intended for orogastric,
nasogastric, or rectal insertion to sample carbon
dioxide (CO2) from the mucosal vasculature of the
72 Gastric tonometry catheter B
stomach or sigmoid colon for the measurement of
partial pressure (i.e., tonometry) of CO2 (pCO2)
during diagnosis of mensenteric ischemia.
An implantable device intended to be used to join
Gastrointestinal and transect excess tissue of gastrointestinal
73 anastomosis coupler, structures through the coupling of two ring-shaped D
bioabsorbable components that are inserted into the ends of the
segments to be attached.
An implantable device intended to be used to join
Gastrointestinal and transect excess tissue of gastrointestinal
74 anastomosis coupler, non- structures through the coupling of two ring-shaped C
bioabsorbable components that are inserted into the ends of the
segments to be attached.
A multicomponent assembly of mains electricity
(AC-powered) devices designed for real-time
visualization/navigation of a catheter and/or
Gastrointestinal
endoscope during insertion in the gastrointestinal
75 catheter/endoscope B
tract, by detecting its position/movement within an
tracking system
electromagnetic (EM) field and displaying three-
dimensional (3-D) virtual images on a monitoring
screen.
A device intended to be used in combination with a
compatible flexible endoscope for the application of
a gastrointestinal endoscopic clip(s) [not included] to
Gastrointestinal the mucosal lining of the gastrointestinal (GI) tract
76 B
endoscopic clip applier for endoscopic marking, haemostasis, tissue
approximation, closure of luminal perforations,
and/or for treating mucosal/submucosal defects
during an endoscopic procedure.
A sterile device intended to be used in combination
Gastrointestinal
77 with a generator to remove a gastrointestinal C
endoscopic clip cutter
endoscopic clip.
A portable, mains electricity (AC-powered) device
Gastrointestinal
intended to be used in conjunction with a cutter for
78 endoscopic clip cutter C
the endoscopic removal of a gastrointestinal
generator
endoscopic clip.
A sterile clip intended to be implanted long-term
(>30 days) within the gastrointestinal (GI) tract
Gastrointestinal during an endoscopic procedure for endoscopic
79 C
endoscopic clip, long-term marking, haemostasis, tissue approximation, closure
of luminal perforations, and/or for treating
mucosal/submucosal defects.
Page 8 of 17A sterile clip intended to be placed short-term (<=30
days) within the gastrointestinal (GI) tract during an
Gastrointestinal endoscopic procedure for endoscopic marking,
80 B
endoscopic clip, short-term haemostasis, tissue approximation, closure of
luminal perforations, and/or for treating
mucosal/submucosal defects.
A non-sterile flexible tube with electronic sensors at
the distal end intended to be inserted through the
nose or rectum into the gastrointestinal (GI) tract to
Gastrointestinal
evaluate peristaltic motility anywhere in the GI tract
81 manometric catheter, B
(pharynx, oesophagus, stomach, duodenum, small
electronic
bowel, colon, and anorectal area) by measuring
pressure; it may additionally be intended to measure
pH and electrical impedance and contain a lumen.
A non-sterile, non-electrical flexible tube intended to
be inserted through the nose or rectum into the
gastrointestinal (GI) tract for measuring pressure to
Gastrointestinal
assess peristaltic motility in the GI tract (e.g.,
82 manometric catheter, non- B
oesophagus, stomach) or rectal musculature and
electronic
anal sphincter functions, typically in the evaluation of
GI disorders [e.g., gastro-oesophageal reflux
disease (GERD), faecal incontinence].
A non-sterile, noninvasive pouch designed to be
wrapped around the protruding end of a
Gastrointestinal ostomy
83 gastrointestinal ostomy tube (e.g., gastrostomy or A
tube pocket
jejunostomy tube) to hold and support it in order to
ensure its stabilization on the patient.
A sterile, thin, flexible, hollow cylinder
percutaneously inserted into the stomach, typically
through puncture of the abdominal wall and stomach
after distention of the stomach by endoscopic
methods, with an extended portion inserted through
the pylorus into the jejunum. It is used to feed a
patient who has a physical disability that prevents
84 Gastrojejunostomy tube C
oral feeding (e.g., a birth defect of the mouth,
oesophagus, or stomach, or a neuromuscular
condition that affects chewing and swallowing), and
to provide drainage/decompression for the stomach
when it is necessary to bypass a longstanding
obstruction of the stomach outlet into the small
intestine.
An implantable device introduced into the gastro-
Gastro-oesophageal oesophageal sphincter to reduce a sliding hiatal
85 C
antireflux prosthesis hernia, preventing the reflux of gastric contents into
the oesophagus.
Page 9 of 17A non-sterile flexible tube with electronic sensors at
its distal end intended to be inserted through the
Gastro-oesophageal nose into the oesophagus and stomach to measure
86 pH/impedance catheter, pH and/or electrical impedance, typically for the B
non-sterile evaluation of gastro-oesophageal reflux disease
(GERD), gastric ulcers, or other gastrointestinal
conditions.
A sterile flexible tube with an with an electrical
conductor at its distal end intended to be inserted
Gastro-oesophageal through the nose into the oesophagus and stomach
87 pH/impedance catheter, to measure pH and/or electrical impedance, typically B
sterile for the evaluation of gastro-oesophageal reflux
disease (GERD), gastric ulcers, or other
gastrointestinal conditions.
A collection of non-sterile devices designed as the
external portion of a gastrostomy aspiration system
intended to be used post-surgery by the patient after
Gastrostomy aspiration implantation of the stomach tube for the removal of
88 C
system gravity set a portion of stomach contents after meals, by
aspiration, to achieve portion control and
subsequently weight loss in a morbidly obese
(bariatric) patient (≥ 18 years).
A sterile, thin, flexible, hollow cylinder intended to be
percutaneously implanted by endoscopic methods
into the stomach of a morbidly obese (bariatric)
Gastrostomy aspiration
89 patient (≥ 18 years) for the removal of a portion of C
system stomach tube
stomach contents after meals by aspiration when
used with a dedicated gravity kit that is the external
portion of a gastrostomy aspiration system.
A sterile, short, tube that is inserted into the stomach
90 Gastrostomy button C
percutaneously to permit long-term enteral feeding.
A device intended to be inserted into the stomach
percutaneously to appose the anterior gastric wall to
the anterior abdominal wall, typically to facilitate the
91 Gastrostomy T fastener C
insertion of a percutaneous gastrostomy tube or for
procedures requiring stabilization/fixation of hollow
gastrointestinal (GI) structures.
A sterile connecting device shaped in the form of a
"Y" intended for connection to the proximal end of a
Gastrostomy tube Y-piece
92 gastrostomy tube to enable administration of nutrient B
connector
liquids and/or medication through the gastrostomy
tube.
A slender, rod-like surgical instrument made of
metal, typically with groove running along the centre
of it distal shaft and/or continuing with an elongated
93 Gastro-urological director malleable wire loop, that is used to guide other B
devices or instruments into a selected intracorporeal
location during a gastroenterological/urological (GU)
procedure.
Page 10 of 17A slender, rod-like, hand-held manual surgical
instrument, typically made of flexible metal with a
94 Gastro-urological probe blunt bulbous tip, designed for exploring B
gastroenterological/urological (GU) structures during
a GU procedure.
A heavy, hand-held, manual surgical instrument with
a spoon-like, sharp-edged distal end on a long thin
95 Gastro-urological scoop shaft that is used to access and scrape tissue from B
the common hepatic/bile duct system during a
gastroenterological/urological (GU) procedure.
A collection of devices intended to be used to deliver
96 Gravity enema set an injection of fluid (e.g., saline solution) into the A
rectum to facilitate evacuation of the large intestine.
A sterile implantable device designed to isolate the
lesser curvature segment of the stomach
(magenstrasse) to reduce stomach volume and
97 Implantable gastric clamp C
facilitate weight loss in overweight/obese patients
through a reduction in food consumption based on
an increased sense of satiety (fullness).
An assembly of battery-powered devices intended to
treat chronic disorders of the pelvis and lower
Implantable incontinence-
urinary or intestinal tract, typically related to urinary
98 control electrical C
and/or faecal incontinence, through the application
stimulation system
of electrical stimuli to the muscles and/or neural
tissue of the pelvic floor/bladder.
A small, sterile, implantable device designed to
Implantable peritoneal secure a peritoneal or lumboperitoneal catheter in
99 C
catheter holder situ by suturing it to the abdominal fascia at the point
of entry/exit.
A non-sterile, noninvasive device intended to be
Intestinal ostomy bag anti- applied to the inner surface of an intestinal ostomy
100 A
adhesion device bag to prevent opposing inner walls of the bag from
sticking together (anti-pancaking).
A collection of non-sterile devices intended to be
used for attachment/replacement of an intestinal
101 Intestinal ostomy kit ostomy bag (for collecting intestinal output such as A
faeces following a colostomy or ileostomy
procedure).
A sterile rigid or flexible device intended to be
implanted within the abdomen to stabilize a portion
102 Intestinal splint C
of the intestine, or to stabilize and protect an injured
portion of the intestine.
A non-sterile plate, typically with a waist belt for
attachment, intended to be placed over an enteric
Intestinal stoma stoma (surgically-created artificial opening between
103 shield/support belt, the intestines and the body surface through which A
reusable bodily waste is drained) to protect it from harmful
external influences (e.g., knocks, friction), to reduce
the risk of stomal herniation, or to help maintain
Page 11 of 17adhesion of the base plate to the skin.
A non-sterile plate, typically with a waist belt for
attachment, intended to be placed over an enteric
stoma (surgically-created artificial opening between
Intestinal stoma
the intestines and the body surface through which
104 shield/support belt, single- A
bodily waste is drained) to protect it from harmful
use
external influences (e.g., knocks, friction), to reduce
the risk of stomal herniation, or to help maintain
adhesion of the base plate to the skin.
A sterile, hand-held manual surgical instrument
intended to be inserted through an orogastric (or
nasogastric) tube to mechanically divert the
Intraluminal oesophageal
105 oesophagus away from the site of surgery during B
retractor
electrical treatments of the heart (e.g., cardiac
ablation), to facilitate surgical site access and to
help prevent injury to the oesophagus.
A sterile, flat stretch of silicone elastomer intended
for use as a short-term intra-abdominal dressing
following abdominal surgery, when a re-exploration
Invasive silicone sheet
106 of the wound/abdomen is planned within a thirty day B
dressing
period. It is used to achieve temporary abdominal
closure to avoid the complications of an open
abdomen.
A sterile, flexible, single-lumen tube with a distal
Laparoscopic
needle intended to puncture the neck of the
107 cholangiography B
gallbladder (Hartmann’s pouch) during laparoscopic
catheter/needle
cholangiography to allow injection of contrast media.
A sterile, rigid surgical instrument designed to be
Laparoscopic grasping introduced through a laparoscope primarily for
108 A
forceps, Non sterile grasping and manipulating tissues during a
laparoscopic surgical procedure.
A rigid surgical instrument designed to be introduced
Laparoscopic grasping through a laparoscope primarily for grasping and
109 B
forceps, sterile manipulating tissues during a laparoscopic surgical
procedure.
An instrument designed to grasp a pledget swab at
the distal end to obtain cytological specimens and/or
Laparoscopic swab
110 to perform blunt dissection during gynaecologic B
forceps
and/or other (e.g., cholecystectomy) laparoscopic
procedures.
Page 12 of 17A non-sterile device intended to be used to manually
administer fluid (e.g., saline solution) into the rectum
111 Manual enema device to facilitate evacuation of the large intestine through B
expansion of the lower intestinal tract and physical
stimulation of peristalsis.
A device intended to be used to manually administer
fluid (e.g., saline solution) into the rectum to facilitate
Manual enema device,
112 evacuation of the large intestine through expansion B
reusable
of the lower intestinal tract and physical stimulation
of peristalsis.
A portable assembly of manually-operated devices
designed to be used by or on a patient to irrigate the
Manual rectal irrigation rectum with water, typically to provoke the
113 B
system defecation reflex for the evacuation of the bowels to
treat/prevent constipation and reduce the risk of
faecal incontinence.
A mains electricity (AC-powered) motorized surgical
Motorized laparoscopic instrument designed for grasping, mobilizing, and
114 B
forceps suturing tissues/vessels under direct or endoscopic
visualization during a surgical procedure.
A sterile, thin, flexible, hollow cylinder designed to
access the small intestines (duodenum or jejunum)
through the nose and nasopharynx for examination
115 Nasoenteral tube B
(e.g., of intestinal contents), treatment (e.g.,
decompression, short-term feeding), or other
purposes.
A non-sterile, non-surgically invasive device
Nasogastric tube holder, intended to be used to secure a nasogastric tube to
116 B
intranasal the nose of a patient to prevent displacement or
removal of the tube.
A small, non-sterile, noninvasive device intended to
Nasogastric tube holder, be used to secure a nasogastric tube to prevent
117 A
noninvasive, non-sterile displacement or removal of the tube from the
patient.
A small, sterile, noninvasive device intended to be
Nasogastric tube holder, used to secure a nasogastric tube to prevent
118 A
noninvasive, sterile displacement or removal of the tube from the
patient.
A collection of sterile, invasive devices intended to
Non-vascular catheter enable percutaneous Seldinger-type introduction of
119 B
introduction set a non-vascular catheter (e.g., drainage catheter) into
a body cavity or lumen (e.g., biliary tract, ureter).
An electronic device used to monitor the
temperature of the oesophagus during surgical
ablation of the wall of the left atrium. It typically
Oesophageal temperature
120 measures the oesophageal temperature at several B
monitor
adjacent levels, and displays these temperature
values simultaneously to help the surgeon avoid the
application of heat high enough to form atrial-
Page 13 of 17oesophageal fistulas.
A sterile, thin, flexible, hollow cylinder designed as a
Paediatric-temperature paediatric or neonatal enteral feeding tube with an
121 C
nasogastric/orogastric tube integrated temperature sensor that continuously
measures oesophageal temperature.
A sterile partially-implantable device intended to
Partially-implantable
122 provide access to the peritoneal cavity for infusion C
abdominal port/catheter
(e.g., insulin, chemotherapeutic agents).
A collection of sterile devices intended to be used to
obtain a tissue specimen from within the biliary duct
Percutaneous biliary
123 system for histological analysis by a percutaneous B
biopsy procedure kit
endoscopic approach, typically under fluoroscopic
visualization.
A sterile, flexible tubular device intended to deliver
Pharyngeal electrical
124 pharyngeal electrical stimulation for the treatment of C
stimulation catheter
neurogenic dysphagia.
A portable assembly of battery-powered devices
intended to be used by, or on a patient, for the
Powered rectal/colostomy controlled introduction of a non-medicated solution
125 B
irrigation system (typically water) into the rectum to treat faecal
incontinence or constipation (rectal irrigation), and/or
for colostomy site irrigation.
A non-sterile substance intended to be applied to
the mucosa of the mouth and/or pharynx to facilitate
saprophytic microflora colonization within the oral
Probiotic oropharyngeal cavity/pharynx, typically following antibiotic therapy,
126 C
mucosa dressing bacterial infection, or injury. It includes probiotic
bacteria (e.g., Streptococcus salivarius,
Streptococcus oralis) and compounds that create a
barrier to facilitate growth of the probiotic bacteria.
An endoscope with a rigid inserted portion intended
127 Proctoscope, reusable for the visual examination and treatment of the B
rectum and anus.
A sterile endoscope with a rigid inserted portion
128 Proctoscope, single-use intended for the visual examination and treatment of B
the rectum and anus.
A hand-held manual surgical instrument intended to
129 Rectal speculum be used to expand or stretch the rectal orifice/canal B
after it is inserted and opened.
An assembly of disposable and reusable devices
designed to obtain a submucosal tissue specimen
Rectal suction biopsy
130 from the rectum using suction [rectal suction biopsy B
system
(RSB)], typically for histopathological analysis [e.g.,
to help diagnose Hirschsprung's disease (HD)].
Page 14 of 17A collection of non-sterile, noninvasive devices
intended to be used in conjunction with a rectal
Rectal/colonic lavage
131 and/or colonic irrigation system to support the A
support kit
introduction of an irrigation solution into the
rectum/colon.
An endoscope with a rigid inserted portion intended
132 Rectoscope, reusable for the visual examination and treatment of the B
rectum and anus.
A sterile endoscope with a rigid inserted portion
133 Rectoscope, single-use intended for the visual examination and treatment of B
the rectum and anus.
A manual device intended to be used as a handle to
Rectoscope/proctoscope
134 hold a rectoscope or proctoscope during an A
handle
examination procedure.
A small cap intended to be fitted to the proximal end
of the handle of a rectoscope or proctoscope during
Rectosocope/proctoscope
135 an examination procedure to provide an airtight seal A
handle end-cap
so that air can be pumped through the scope to
inflate the bowel.
An endoscope with a rigid inserted portion intended
136 Rigid oesophagoscope for the visual examination and treatment of the B
oesophagus.
An endoscope with a rigid inserted portion intended
for the visual examination and treatment of the
137 Rigid sigmoidoscope B
sigmoid colon (the distal S-shaped part of the large
intestine leading to the rectum).
A sterile electrosurgical device intended to be
connected directly to the arm of a robotic surgical
system to deliver electrosurgical current in a bipolar
Robotic electrosurgical
configuration (i.e., without a return electrode) from a
138 instrument, bipolar, single- C
generator directly to tissues for
use
cutting/coagulation/ablation during robotic
endoscopic (e.g., laparoscopic, arthroscopic)
surgery.
A surgical device intended to be used in conjunction
139 Robotic surgical retractor with a robotic surgical system to enable retraction of B
tissues during a robotic endoscopic procedure.
A sterile endoscope with a highly-flexible, self-
Self-propelled flexible
140 propelled, inserted portion intended for the visual B
video colonoscope
examination of the entire colon.
A slender, sharply-pointed metal tube designed to
introduce or remove gas from the peritoneal cavity
Spring-loaded as a therapeutic or surgical/radiological procedural
141 pneumoperitoneum method. It is often inserted into the peritoneal cavity B
needle, reusable for the purpose of insufflation [e.g., with carbon
dioxide (CO2)] to establish pneumoperitoneum prior
to abdominal endoscopy.
Page 15 of 17A slender, sharply-pointed metal tube designed to
introduce or remove gas from the peritoneal cavity
Spring-loaded as a therapeutic or surgical/radiological procedural
142 pneumoperitoneum method. It is often inserted into the peritoneal cavity B
needle, single-use for the purpose of insufflation [e.g., with carbon
dioxide (CO2)] to establish pneumoperitoneum prior
to abdominal endoscopy.
A non-sterile magnetic device designed to be
inserted into the rectum by the user and retained
143 Static magnetic anal plug there for a specified period of time (e.g., 1 to 2 hours B
per day for 10 to 20 days) to help reduce anal
haemorrhoids with magnetism.
A sterile flexible tube that is inserted into a stoma
(an artificial opening in the body, especially in the
144 Stoma drainage catheter abdominal wall, made during a surgical procedure) B
to drain bodily waste from an internal stoma
container; normally directly into the toilet.
A sterile, non-bioabsorbable device intended to be
implanted into the abdominal wall during a gastro-
145 Stoma support implant urological ostomy procedure to reduce the risk of C
parastomal hernia by supporting the abdominal wall
surrounding the stoma.
An endoscope with a rigid inserted portion intended
TEM/TEO rectoscope, for surgical treatment of the lower part of the bowel
146 B
optical during transanal endoscopic microsurgery (TEM) or
transanal endoscopic operations (TEO).
An endoscope with a rigid inserted portion intended
TEM/TEO rectoscope, for surgical treatment of the lower part of the bowel
147 B
video during transanal endoscopic microsurgery (TEM) or
transanal endoscopic operations (TEO).
A non-sterile, multi-lumen, multi-purpose tube
intended for oral introduction into the gastrointestinal
(GI) tract for both: 1) enteral feeding/gastric
Thermal-regulation
148 decompression; and 2) thermal regulation of the C
orogastric tube
whole body via thermal transfer across the
oesophagus (to lower and alternatively elevate core
body temperature).
A sterile non-bioabsorbable tube intended to be
endoscopically implanted transmurally between the
149 Transenteric drainage tube C
gastrointestinal (GI) tract and a pancreatic
pseudocyst or the biliary tract for drainage.
An assembly of electronic devices designed for the
internal visualization and examination of sections of
Video capsule endoscopy
150 the gastrointestinal (GI) tract using a non-digestible B
system
video capsule after it has been swallowed by a
patient.
Page 16 of 17An individual software application program or group
Video capsule endoscopy
of programs, routines or algorithms that add specific
151 system application B
computer assisted display, processing and analysis
software
capabilities to a video capsule endoscopy system.
A non-sterile, battery-powered, electronic
component device of a video capsule endoscopy
Video capsule endoscopy
152 system designed to be swallowed by a patient for B
system capsule
the internal visualization and examination of the
gastrointestinal (GI) tract.
Pancreatic duct stents are often placed in
153 Pancreatic stent C
patients who have chronic pancreatitis.
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