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G-EYE Colonoscope

FDA UDI

Class II (US FDA UDI)

by Smart Medical Systems Ltd

Identity

Trade Name
G-EYE Colonoscope FDA UDI
Generic Name
Flexible fibreoptic colonoscope FDA UDI
Device Name
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning. FDA UDI
Model / Reference
G-EYE760S-V/L FDA UDI
Description
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning. FDA UDI

Identifiers

Catalog Number
40-596 FDA UDI
Primary DI / UDI-DI
07290018671030 FDA UDI
510(k) Number
K202469 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Flexible fibreoptic colonoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Flexible fibreoptic colonoscope

G-EYE Colonoscope by Smart Medical Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic colonoscope.

Cleared under the same submission

K202469 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smart Medical Systems Ltd

Sources (1)

  • FDA UDI 8a7b6f09-c02e-4bc3-9952-aa3cc426aa46 37 fields · synced Jun 8, 2026