FDA Product Code FED: Endoscopic Access Overtube, Gastroenterology-urology
Under FDA product code FED, endoscopic access overtubes are cleared to facilitate repeated endoscope passage and protect the esophagus during complex procedures.
These rigid or semi-rigid tubes are placed over the endoscope to provide a stable, protected channel for repeated instrument insertion during procedures requiring multiple passes — such as large polypectomy, foreign body removal, and push enteroscopy.
FED devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Calyxo, Inc., Hunan Vathin Medical Instrument Co., Ltd. and Zhejiang Yigao Medical Technology Co., Ltd..
FDA 510(k) Cleared Endoscopic Access Overtube, Gastroenterology-urology Devices (Product Code FED)
About Product Code FED - Regulatory Context
510(k) Submission Activity
101 total 510(k) submissions under product code FED since 1981, with 101 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for FED submissions have been consistent, averaging 106 days recently vs 112 days historically.
FED devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →