# K162622: Fujifilm Endoscope Models EC-600HL and EC-600LS

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Oct 18, 2016 after 28 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: 5 generations back to K944759 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143732: FUJIFILM Endoscope Models EC-600HL and EC-600LS, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K180405: FUJIFILM Endoscope Models EC-600HL and EC-600LS (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K162622
Methodology: https://510kreport.com/methodology