# K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Nov 10, 2004 after 119 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944759 (1995). 2 ancestors in all.
75 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944620: Series 400 Gastroenterology System, Marks & Murase (1995) Summary page 1.
- K944759: 200 Series Gastro-Intestinal Video System, Fujinon, Inc. (1995) Summary page 1.

## Most influential descendants
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), 45 descendants of its own
- K112391: Fujinon Colonoscopes (2012), 33 descendants of its own
- 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
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), 19 descendants of its own

## Recalls of this device
- Mar 27, 2006 · Not classified · Z-0708-06: Colonoscope insertion tube is not bending properly and is stiff.

## Indications for use
The 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/K041903
Methodology: https://510kreport.com/methodology