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Panels › Gastroenterology, Urology › Product code FET · Class 2

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Regulation 876.1500

3510(k)s in 12 months (101 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in FET

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.130
Olympus Medical Systems Corp.100
Richard Wolf Medical Instruments Corp.80
Karl Storz Imaging, Inc.50
Fujifilm Corporation30
Fujinon, Inc.30
Olympus America, Inc.30
Olympus Corporation of the Americas03
Precise Optics30
Aizu Olympus Co., Ltd.02
Decided510(k)Device and applicantCode
Sep 10, 2026K2620794K Camera Head OLYMPUS CH-S700-08-LB
Olympus Medical Systems Corp., JP
FET
Jul 2, 2026K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Fujifilm Corporation, JP
FET
Jun 24, 2026K261260HD Camera Head OLYMPUS CH-S200-08-LB
Olympus Medical Systems Corporation, JP
FET
Sep 24, 2025K251734ProVee Video Processing Unit (PV-003)
Proverum Limited, IE
FET
Aug 11, 2025K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
Univlabs Technologies Private Limited, IN
FET
Jul 1, 2025K250204Endoscopic Camera System
Shenzhen Sophway Technology Co., Ltd., CN
FET
Apr 11, 2025K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
Fujifilm Corporation, JP
FET
Apr 2, 2025K242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEA
Olympus Corporations of the Americas
FET
Feb 7, 2025K243321Endoscopic Video Image Processor (RP-IPD-V1000F)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FET
Oct 22, 2024K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
Shanghai SeeGen Photoelectric Technology Co., Ltd., CN
FET
Jul 3, 2024K241371VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Olympus Medical Systems Corporation, JP
FET
Apr 26, 2023K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS
Olympus Medical Systems Corporation, JP
FET
Jun 14, 2022K212808Logic Hd camera head green, System green
Richard Wolf Medical Instruments Corporation
FET
May 13, 2022K221174Telepack +
Karl Storz Endoscopy America, Inc.
FET
Oct 1, 2021K211332D Camera Controller
Richard Wolf Medical Instruments Corporation
FET
Oct 29, 2020K202646Visera Elite II Video System Center
Olympus Medical Systems Corp., JP
FET
Sep 1, 2020K201135Image1 S CCU, Image1 S 4U Camera Head
KARL STORZ Endoscopy-America, Inc.
FET
Jul 22, 2020K201200Visera Elite II Video System Center
Olympus Medical Systems Corp., JP
FET
Jun 23, 2020K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
Richard Wolf Medical Instruments Corporation
FET
May 1, 2020K192286FUJIFILM EP-6000 Video Processor
Fujifilm Corporation, JP
FET
Dec 20, 2019K193235Telepack +
Karl Storz Endoscopy America, Inc.
FET
Aug 30, 2019K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Hea
Olympus Medical Systems Corp., JP
FET
Mar 29, 2019K190648Pusen Eview Medical Video Endoscope Image Processor
Zhuhai Pusen Medical Technology Co., Ltd., CN
FET
Nov 20, 2018K182696Telepack X LED
KARL STORZ Endoscopy-America, Inc.
FET
Jun 28, 2018K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
Richard Wolf Medical Instruments Corporation
FET
May 24, 2018K180414EPX-4440FN Digital Video Processor with Light Source
Fujifilm New Development U.S.A., Inc.
FET
Oct 17, 2017K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
Olympus Medical Systems Corp., JP
FET
Apr 25, 2017K163675Processor VP-7000, Light Source BL-7000
Fujifilm Medical System U.S.A., Inc.
FET
Jan 11, 2017K161204ENDOCAM Flex HD Camera System 5521
Richard Wolf Medical Instruments Corporation
FET
Feb 1, 2016K160044Image1 SPIES System
Karl Storz Endoscopy America, Inc.
FET
Oct 13, 2015K152109HD-Camera HDC1000
W.O.M. World of Medicine GmbH, DE
FET
Oct 1, 2015K150221EPX-4440HD and EPX-4400HD with FICE
Fujifilm Medical System U.S.A., Inc.
FET
Dec 20, 2013K131953IMAGE1 SPIES
KARL STORZ Endoscopy-America, Inc.
FET
Apr 3, 2013K130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
Richard Wolf Medical Instruments Corp.
FET
Jun 22, 2012K113873PENTAX EPK-I5020 VIDEO PROCESSOR
Pentax of America, Inc.
FET
Apr 6, 2012K111997IMAGE1 GI CCU MODEL 22203020-114
KARL STORZ Endoscopy-America, Inc.
FET
Jun 15, 2011K102949COLONOSCOPY ASSISTANT
Sti Medical Systems, LLC
FET
May 25, 2011K102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
Fujinon, Inc.
FET
Oct 8, 2010K102059AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
Olympus Medical Systems Corporation
FET
May 18, 2009K090800VS-100 ILLUMINATION AND IMAGING SYSTEM
Schoelly Imaging, Inc.
FET
Jan 13, 2009K083155HD CAMERA HEAD OTV-S7PROH-HD-L08E
Olympus Medical Systems Corporation
FET
Aug 11, 2008K080809IEC MEDSIGHT AND MEDBRIGHT
Innovative Endoscopy Components, LLC
FET
Jun 20, 2008K081585ENDOSCOPY VIDEO CAMERA SYSTEM
Vision Systems Group, A Division of Viking Systems
FET
May 31, 2007K070716IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
KARL STORZ Endoscopy-America, Inc.
FET
Apr 4, 2005K043324AIDA WITH DICOM AND HL7 INTERFACE
KARL STORZ Endoscopy-America, Inc.
FET
Jul 1, 2004K041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
Olympus Corporation
FET
Sep 23, 2003K031895KSEA OPSERVER LAP
KARL STORZ Endoscopy-America, Inc.
FET
Sep 2, 2003K032545ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
Mgb Endoskopische Gerate GmbH (Berlin), DE
FET
Sep 2, 2003K032544VP-1000; MED CAM 100; VP-3000A; MED CAM 300
Mgb Endoskopische Gerate GmbH (Berlin), DE
FET
Jan 29, 2003K0236591-CCD ENDOCAM 5520 SYSTEM
Richard Wolf Medical Instruments Corp.
FET

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