FDA Product Code FET: Endoscopic Video Imaging System/component, Gastroenterology-urology
FDA product code FET covers endoscopic video imaging systems and components for gastrointestinal endoscopy.
These systems integrate a high-definition camera, light source, and image processing unit to display real-time video images of the gastrointestinal tract during endoscopy. Advanced systems include narrow-band imaging, chromoendoscopy, and AI-assisted polyp detection capabilities.
FET 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, KARL STORZ Endoscopy-America, Inc. and Fujifilm Corporation.
List of Endoscopic Video Imaging System/component, Gastroenterology-urology devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Endoscopic Video Imaging System/component, Gastroenterology-urology devices (product code FET). 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 →