# K143732: FUJIFILM Endoscope Models EC-600HL and EC-600LS

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jul 6, 2015 after 189 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: 4 generations back to K944759 (1995). 6 ancestors in all.
2 later devices descend 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)
- K132210: Fujifilm 600 Series Endoscopes, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

## Most influential descendants
- K162622: Fujifilm Endoscope Models EC-600HL and EC-600LS (2016), 1 descendant of its own
- K180405: FUJIFILM Endoscope Models EC-600HL and EC-600LS (2018), 0 descendants of its own

## Indications for use
The FUJIFILM Endoscope Models EC-600HL and EC-600LS 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/K143732
Methodology: https://510kreport.com/methodology