# K944759: 200 Series Gastro-Intestinal Video System

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Apr 11, 1995 after 196 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
91 later devices descend from it; 4 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 (2004), 75 descendants of its own
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), 45 descendants of its own
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 (2004), 39 descendants of its own
- K112391: Fujinon Colonoscopes (2012), 33 descendants of its own
- K132210: Fujifilm 600 Series Endoscopes (2014), 25 descendants of its own

## Recalls of this device
- Dec 23, 2015 · Class II · Z-1862-2016: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Dec 23, 2015 · Class II · Z-1861-2016: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Aug 31, 2015 · Class II · Z-0418-2016: A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
- Jun 30, 2015 · Class II · Z-2805-2015: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that wh
- Jun 30, 2015 · Class II · Z-2806-2015: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that wh

Source page: https://510kreport.com/device/K944759
Methodology: https://510kreport.com/methodology