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 Ga Health Company Limited, Erbe USA, Inc. and KARL STORZ Endoscopy-America, Inc..