# K092461: Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Nov 5, 2009 after 86 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 3 generations back to K011016 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060962: Endogator Endoscopy Irrigation Pump, Model Egp-100, Byrne Medical, Inc. (2006) Summary page 1.
- K031773: Endo Gator System, Byrne Medical, Inc. (2003) Summary page 1.
- K033695: Irrigation Channel Tubing, Model 100135, Byrne Medical, Inc. (2003) Summary page 1.
- (no number) Erbe EIP2: named in the summary without a submission number

## Recalls of this device
- Feb 17, 2015 · Class II · Z-1943-2015: The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

## Indications for use
The Irrigation Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract. The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles. The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible endoscope.

Source page: https://510kreport.com/device/K092461
Methodology: https://510kreport.com/methodology