# K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Nov 24, 2004 after 118 days
- Product code: FDS (Gastroscope 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: 1 generation back to K944759 (1995). 2 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 42 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
- 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
- K063316: Fujinon Model EG-530N Trans Nasal Insertion (2007), 10 descendants of its own
- K142629: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (2015), 6 descendants of its own

## Indications for use
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

Source page: https://510kreport.com/device/K042043
Methodology: https://510kreport.com/methodology