# K180405: FUJIFILM Endoscope Models EC-600HL and EC-600LS

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Mar 15, 2018 after 29 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: 6 generations back to K944759 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162622: Fujifilm Endoscope Models EC-600HL and EC-600LS, Fujifilm Medical Systems U.S.A, Inc. (2016) Summary page 4.

## Indications for use
The devices are 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/K180405
Methodology: https://510kreport.com/methodology