# K103239: Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Dec 30, 2010 after 58 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (2021), 6 descendants of its own
- K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (2023), 3 descendants of its own
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (2024), 1 descendant of its own
- K250145: Biopsy Port Adapter (2025), 0 descendants of its own
- K250140: Defendo Fujifilm 700 Single Use Cleaning Adapter (2025), 0 descendants of its own

## Recalls of this device
- Mar 7, 2013 · Class II · Z-1099-2013: The firm was notified by their customers that there was a water leakage from the white tubing connector.

## Indications for use
The Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

Source page: https://510kreport.com/device/K103239
Methodology: https://510kreport.com/methodology