# K180341: FUJIFILM 600 Series Endoscope EG-600WR v2

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Aug 3, 2018 after 177 days
- Product code: FDS (Gastroscope 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: 4 generations back to K944759 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132210: Fujifilm 600 Series Endoscopes, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

## Most influential descendants
- K213095: andorate Suction Valve, andorate Air/Water Valve (2022), 0 descendants of its own

## Indications for use
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Source page: https://510kreport.com/device/K180341
Methodology: https://510kreport.com/methodology