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..
FDA 510(k) Cleared Endoscopic Video Imaging System/component, Gastroenterology-urology Devices (Product Code FET)
About Product Code FET - Regulatory Context
510(k) Submission Activity
98 total 510(k) submissions under product code FET since 1981, with 98 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FET have taken an average of 148 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
FET devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →