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 Shanghai SeeGen Photoelectric Technology Co., Ltd..