# K223827: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Sep 8, 2023 after 261 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: 7 generations back to K944759 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190649: FUJIFILM Endoscope Model EC-760S-V/L, Fujifilm Corporation (2019) Summary page 4.
- DEN210032: AccuMeasure System, RQMIS, Inc. (2022) Summary page 4.

## Most influential descendants
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (2026), 0 descendants of its own

## Indications for use
FUJIFILM Endoscope Model EC-760S-A/L 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. Never use this product for any other purposes. Endoscopy Support Program EW10-VM01 This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.

Source page: https://510kreport.com/device/K223827
Methodology: https://510kreport.com/methodology