# K243261: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: May 23, 2025 after 220 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: 11 generations back to K931154 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 5.
- K190649: FUJIFILM Endoscope Model EC-760S-V/L, Fujifilm Corporation (2019) Summary page 5.
- K183572: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L, Fujifilm Corporation (2019) Summary page 5.
- K222584: Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I, Gastrointestinal Videoscope Olympus Gif-1100, Olympus Medical Systems Corporation (2023) Summary page 5.

## Indications for use
This product 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/K243261
Methodology: https://510kreport.com/methodology