# K180711: FUJIFILM Endoscopic CO2 Regulator GW-100

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: May 25, 2018 after 67 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- 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: 3 generations back to K881004 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133976: Fujifilm Endoscopic CO2 Regulator, Fujifilm Medical System U.S.A., Inc. (2014) Summary page 4.

## Indications for use
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

Source page: https://510kreport.com/device/K180711
Methodology: https://510kreport.com/methodology