# K220158: G-EYE System

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Apr 11, 2022 after 82 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931154 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202469: G-EYE System, Smart Medical Systems, Ltd. (2020) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K220158
Methodology: https://510kreport.com/methodology