FDA Product Code OCX: Endoscopic Irrigation/suction System
Under FDA product code OCX, endoscopic irrigation and suction systems are cleared for fluid management during gastrointestinal endoscopy.
These devices supply sterile water or saline to wash the endoscopic view and aspirate fluid, debris, and secretions from the gastrointestinal lumen during diagnostic and therapeutic procedures, maintaining visualization and enabling safe intervention.
OCX devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Olympus Medical Systems Corporation, Erbe USA, Inc. and Hobbs Medical, Inc..
List of Endoscopic Irrigation/suction System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Endoscopic Irrigation/suction System devices (product code OCX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →