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 Coloplast Corp., Fujifilm Corporation and Boston Scientific Corporation.
List of Endoscopic Access Overtube, Gastroenterology-urology devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Endoscopic Access Overtube, Gastroenterology-urology devices (product code FED). 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 →