FET · Class II · 21 CFR 876.1500

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 KARL STORZ Endoscopy-America, Inc., Richard Wolf Medical Instruments Corporation and Olympus Medical Systems Corp..

98
Total
98
Cleared
107d
Avg days
1981
Since
Growing category - 8 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 148d recently vs 103d historically

FDA 510(k) Cleared Endoscopic Video Imaging System/component, Gastroenterology-urology Devices (Product Code FET)

98 devices
1–24 of 98
Cleared Sep 24, 2025
ProVee Video Processing Unit (PV-003)
K251734
Proverum Limited
Gastroenterology & Urology · 110d
Cleared Aug 11, 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462
Univlabs Technologies Private Limited
General & Plastic Surgery · 174d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Apr 11, 2025
FUJIFILM Processor EP-8000
K243260
Fujifilm Corporation
Gastroenterology & Urology · 178d
Cleared Apr 02, 2025
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
K242067
Olympus Corporations of the Americas
General & Plastic Surgery · 261d
Cleared Feb 07, 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321
Guangzhou Red Pine Medical Instrument Co., Ltd.
Gastroenterology & Urology · 107d
Cleared Oct 22, 2024
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
K241532
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Gastroenterology & Urology · 145d
Cleared Jul 03, 2024
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K241371
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 49d
Cleared Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
K222584
Olympus Medical Systems Corporation
Gastroenterology & Urology · 243d
Cleared Jun 14, 2022
Logic Hd camera head green, System green
K212808
Richard Wolf Medical Instruments Corporation
General & Plastic Surgery · 284d
Cleared May 13, 2022
Telepack +
K221174
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 18d
Cleared Oct 01, 2021
D Camera Controller
K211332
Richard Wolf Medical Instruments Corporation
Gastroenterology & Urology · 151d
Cleared Oct 29, 2020
Visera Elite II Video System Center
K202646
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 48d
Cleared Sep 01, 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d
Cleared Jul 22, 2020
Visera Elite II Video System Center
K201200
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 79d
Cleared Jun 23, 2020
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
K200617
Richard Wolf Medical Instruments Corporation
Gastroenterology & Urology · 106d
Cleared May 01, 2020
FUJIFILM EP-6000 Video Processor
K192286
Fujifilm Corporation
Gastroenterology & Urology · 253d
Cleared Dec 20, 2019
Telepack +
K193235
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 30, 2019
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
K190449
Olympus Medical Systems Corp.
Gastroenterology & Urology · 186d
Cleared Mar 29, 2019
Pusen Eview Medical Video Endoscope Image Processor
K190648
Zhuhai Pusen Medical Technology Co., Ltd.
Gastroenterology & Urology · 16d
Cleared Nov 20, 2018
Telepack X LED
K182696
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 54d
Cleared Jun 28, 2018
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
K180583
Richard Wolf Medical Instruments Corporation
Gastroenterology & Urology · 115d
Cleared May 24, 2018
EPX-4440FN Digital Video Processor with Light Source
K180414
Fujifilm New Development U.S.A., Inc.
Gastroenterology & Urology · 98d
Cleared Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
K172817
Olympus Medical Systems Corp.
Gastroenterology & Urology · 29d

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 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FET Product Code

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 →