# K192588: G-EYE System

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Apr 15, 2020 after 209 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: 10 generations back to K931154 (1993). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181084: PENTAX Video Colonoscopes (EC Family), Pentax of America, Inc. (2019) Summary page 4.

## Most influential descendants
- K202469: G-EYE System (2020), 1 descendant of its own
- K220158: G-EYE System (2022), 0 descendants of its own

## 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/K192588
Methodology: https://510kreport.com/methodology