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 Shenzhen Trious Medical Technology Co., Ltd..