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..

101
Total
101
Cleared
105d
Avg days
1981
Since
101 devices
49–72 of 101
Cleared Sep 02, 2003
ENDOSCOPIC LIGHT SOURCE LS-3000X
K032545
Mgb Endoskopische Gerate GmbH (Berlin)
Gastroenterology & Urology · 15d
Cleared Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K020301
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 20, 2001
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K012660
Gimmi GmbH
Gastroenterology & Urology · 129d
Cleared Nov 16, 2001
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709
Hill-Rom, Inc.
Gastroenterology & Urology · 8d
Cleared Apr 27, 2001
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
K003325
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 185d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 174d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 03, 2000
KSEA SCB-RUI
K994348
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 04, 2000
KARL STORZ AUTOCLAVABLE CAMERA HEAD
K994090
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 15, 1999
KSEA SCBCOM
K992469
Karl Storz Endoscopy
Gastroenterology & Urology · 81d
Cleared Aug 05, 1999
FLEXISCOPE IQ 101
K992362
Schoelly Fiberoptic GmbH
Gastroenterology & Urology · 21d
Cleared Jul 29, 1998
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
K981856
Greatbatch Scientific
Gastroenterology & Urology · 63d
Cleared Jul 28, 1998
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
K981827
Angiolaz, Inc.
Gastroenterology & Urology · 67d
Cleared Dec 03, 1997
S-357 VIDEO IMAGING SYSTEM
K973798
Sopro
Gastroenterology & Urology · 58d
Cleared Nov 24, 1997
KARL STORZ DIRECT COUPLED CAMERA HEAD
K973252
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 87d
Cleared Sep 18, 1997
S-357 VIDEO IMAGING SYSTEM
K972540
Sopro
Gastroenterology & Urology · 73d
Cleared Jul 16, 1997
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K971416
Olympus America, Inc.
Gastroenterology & Urology · 91d
Cleared May 20, 1997
VISTA SINGLE CHIP VIDEO CAMERA
K971373
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 36d
Cleared Dec 13, 1996
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
K964173
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 56d
Cleared Jul 09, 1996
S-57 VIDEO IMAGING SYSTEM
K962024
Del Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Mar 29, 1996
EVIS 140 SYSTEM
K954451
Olympus America, Inc.
Gastroenterology & Urology · 186d
Cleared Nov 14, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
K954734
The Tulip Mfg. Co.
Gastroenterology & Urology · 42d
Cleared Oct 23, 1995
KSEA REVERSE VIDEO
K952482
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 146d