# K132210: Fujifilm 600 Series Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jan 10, 2014 after 178 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: 3 generations back to K944759 (1995). 5 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112391: Fujinon Colonoscopes, Fujinon, Inc. (2012) Summary page 2.
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5, Fujinon, Inc. (2004) Summary page 2.
- K944620: Series 400 Gastroenterology System, Marks & Murase (1995) Summary page 4.

## Most influential descendants
- K160196: Fujifilm Video Colonoscope Model EC-600WL V2 (2016), 19 descendants of its own
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (2018), 18 descendants of its own
- K183572: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L (2019), 5 descendants of its own
- K182836: FUJIFILM Endoscope Model EG-740N (2019), 4 descendants of its own
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (2024), 3 descendants of its own

## Indications for use
This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose. Fujifilm 600 Series Endoscope EC-600WL: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Fujifilm 600 Series Endoscope EG-600WR: 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/K132210
Methodology: https://510kreport.com/methodology