# K112391: Fujinon Colonoscopes

- Pathway: 510(k) (Special)
- Applicant: Fujinon, Inc.
- Decided: Jul 26, 2012 after 342 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: 2 generations back to K944759 (1995). 3 ancestors in all.
33 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5, Fujinon, Inc. (2004) Summary page 1.

## Most influential descendants
- K132210: Fujifilm 600 Series Endoscopes (2014), 25 descendants of its own
- K160196: Fujifilm Video Colonoscope Model EC-600WL V2 (2016), 19 descendants of its own
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (2018), 18 descendants of its own
- K142629: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (2015), 6 descendants of its own
- K210162: Endoscope Model EI-740D/S (2021), 5 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/K112391
Methodology: https://510kreport.com/methodology