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, Biotex, Inc. and Zhejiang Chuangxiang Medical Technology Co., Ltd..
FDA 510(k) Cleared Endoscopic Irrigation/suction System Devices (Product Code OCX)
About Product Code OCX - Regulatory Context
510(k) Submission Activity
93 total 510(k) submissions under product code OCX since 1976, with 93 receiving FDA clearance (average review time: 117 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 13 in the prior period.
FDA Review Time
Recent submissions under OCX have taken an average of 140 days to reach a decision - up from 115 days historically. Manufacturers should account for longer review timelines in current project planning.
OCX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →