Product Code: FET
FDA class 2
21 CFR 876.1500
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Gastroenterology, Urology
The Endoscopic Video Imaging System and its components are used to allow visualization of body cavities through an endoscope by projecting images to a monitor, enabling real-time viewing during gastrointestinal and urological endoscopic procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FET, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
510(k)s
96
FEI Numbers
79
Registration Numbers
79
Unique Applicants
62
Years Active
44
Basic Information
- Product Code
- FET
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 96 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250204 | Endoscopic Camera System | Jul 01, 2025 | Substantially Equivalent | Shenzhen Sophway Technology Co., Ltd. |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Apr 11, 2025 | Substantially Equivalent | Fujifilm Corporation |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Apr 02, 2025 | Substantially Equivalent | Olympus Corporations of the Americas |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Feb 07, 2025 | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Oct 22, 2024 | Substantially Equivalent | Shanghai SeeGen Photoelectric Technology Co., Ltd. |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Jul 03, 2024 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | Apr 26, 2023 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K212808 | Logic Hd camera head green, System green | Jun 14, 2022 | Substantially Equivalent | Richard Wolf Medical Instruments Corporation |
| K221174 | Telepack + | May 13, 2022 | Substantially Equivalent | KARL STORZ Endoscopy America, Inc |
| K211332 | D Camera Controller | Oct 01, 2021 | Substantially Equivalent | Richard Wolf Medical Instruments Corporation |
| K202646 | Visera Elite II Video System Center | Oct 29, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | Sep 01, 2020 | Substantially Equivalent | Karl Storz Endoscopy-America, Inc. |
| K201200 | Visera Elite II Video System Center | Jul 22, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | Jun 23, 2020 | Substantially Equivalent | Richard Wolf Medical Instruments Corporation |
| K192286 | FUJIFILM EP-6000 Video Processor | May 01, 2020 | Substantially Equivalent | FUJIFILM Corporation |
| K193235 | Telepack + | Dec 20, 2019 | Substantially Equivalent | Karl Storz Endoscopy America, Inc. |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Aug 30, 2019 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Mar 29, 2019 | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. |
| K182696 | Telepack X LED | Nov 20, 2018 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Jun 28, 2018 | Substantially Equivalent | Richard Wolf Medical Instruments Corporation |
| K180414 | EPX-4440FN Digital Video Processor with Light Source | May 24, 2018 | Substantially Equivalent | FUJIFILM New Development U.S.A., Inc. |
| K172817 | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA | Oct 17, 2017 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K163675 | Processor VP-7000, Light Source BL-7000 | Apr 25, 2017 | Substantially Equivalent | FUJIFILM Medical System U.S.A., Inc. |
| K161204 | ENDOCAM Flex HD Camera System 5521 | Jan 11, 2017 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
| K160044 | Image1 SPIES System | Feb 01, 2016 | Substantially Equivalent | KARL STORZ ENDOSCOPY AMERICA, INC. |
| K152109 | HD-Camera HDC1000 | Oct 13, 2015 | Substantially Equivalent | W.O.M. WORLD OF MEDICINE GmbH |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | Oct 01, 2015 | Substantially Equivalent | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K131953 | IMAGE1 SPIES | Dec 20, 2013 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | Apr 03, 2013 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K113873 | PENTAX EPK-I5020 VIDEO PROCESSOR | Jun 22, 2012 | Substantially Equivalent | PENTAX OF AMERICA, INC. |
| K111997 | IMAGE1 GI CCU MODEL 22203020-114 | Apr 06, 2012 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K102949 | COLONOSCOPY ASSISTANT | Jun 15, 2011 | Substantially Equivalent | STI MEDICAL SYSTEMS, LLC |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | May 25, 2011 | Substantially Equivalent | FUJINON, INC. |
| K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | Oct 08, 2010 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K090800 | VS-100 ILLUMINATION AND IMAGING SYSTEM | May 18, 2009 | Substantially Equivalent | SCHOELLY IMAGING, INC. |
| K083155 | HD CAMERA HEAD OTV-S7PROH-HD-L08E | Jan 13, 2009 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K080809 | IEC MEDSIGHT AND MEDBRIGHT | Aug 11, 2008 | Substantially Equivalent | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
| K081585 | ENDOSCOPY VIDEO CAMERA SYSTEM | Jun 20, 2008 | Substantially Equivalent | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS |
| K070716 | IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL | May 31, 2007 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K043324 | AIDA WITH DICOM AND HL7 INTERFACE | Apr 04, 2005 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K041494 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 | Jul 01, 2004 | Substantially Equivalent | OLYMPUS CORPORATION |
| K031895 | KSEA OPSERVER LAP | Sep 23, 2003 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K032545 | ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 | Sep 02, 2003 | Substantially Equivalent | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
| K032544 | VP-1000; MED CAM 100; VP-3000A; MED CAM 300 | Sep 02, 2003 | Substantially Equivalent | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
| K023659 | 1-CCD ENDOCAM 5520 SYSTEM | Jan 29, 2003 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K020301 | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | Feb 12, 2002 | Substantially Equivalent | VISTA MEDICAL TECHNOLOGIES, INC. |
| K012660 | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES | Dec 20, 2001 | Substantially Equivalent | GIMMI GMBH |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Nov 16, 2001 | Substantially Equivalent | HILL-ROM, INC. |
| K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | Apr 27, 2001 | Substantially Equivalent | KARL STORZ IMAGING, INC. |
| K003113 | KSEA SCB-RUI SCO | Mar 27, 2001 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K003710 | DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 | Feb 02, 2001 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K994348 | KSEA SCB-RUI | Mar 03, 2000 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K994090 | KARL STORZ AUTOCLAVABLE CAMERA HEAD | Feb 04, 2000 | Substantially Equivalent | KARL STORZ IMAGING, INC. |
| K992469 | KSEA SCBCOM | Oct 15, 1999 | Substantially Equivalent | KARL STORZ ENDOSCOPY |
| K992362 | FLEXISCOPE IQ 101 | Aug 05, 1999 | Substantially Equivalent | SCHOELLY FIBEROPTIC, GMBH |
| K981856 | MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) | Jul 29, 1998 | Substantially Equivalent | GREATBATCH SCIENTIFIC |
| K981827 | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | Jul 28, 1998 | Substantially Equivalent | ANGIOLAZ, INC. |
| K973798 | S-357 VIDEO IMAGING SYSTEM | Dec 03, 1997 | Substantially Equivalent | SOPRO |
| K973252 | KARL STORZ DIRECT COUPLED CAMERA HEAD | Nov 24, 1997 | Substantially Equivalent | KARL STORZ IMAGING, INC. |
| K972540 | S-357 VIDEO IMAGING SYSTEM | Sep 18, 1997 | Substantially Equivalent | SOPRO |
| K971416 | OLYMPUS OES OTV-S5C VIDEO SYSTEM | Jul 16, 1997 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K971373 | VISTA SINGLE CHIP VIDEO CAMERA | May 20, 1997 | Substantially Equivalent | VISTA MEDICAL TECHNOLOGIES, INC. |
| K964173 | C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ | Dec 13, 1996 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K962024 | S-57 VIDEO IMAGING SYSTEM | Jul 09, 1996 | Substantially Equivalent | DEL MEDICAL SYSTEMS CORP. |
| K954451 | EVIS 140 SYSTEM | Mar 29, 1996 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K954734 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) | Nov 14, 1995 | Substantially Equivalent | THE TULIP MFG. CO. |
| K952482 | KSEA REVERSE VIDEO | Oct 23, 1995 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K950417 | EPX-310 VIDEO PROCESSOR (ENDOSCOPY) | Jul 21, 1995 | Substantially Equivalent | MARKS & MURASE |
| K950975 | KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS | May 11, 1995 | Substantially Equivalent | KARL STORZ IMAGING, INC. |
| K950974 | KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS | May 11, 1995 | Substantially Equivalent | KARL STORZ IMAGING, INC. |
| K944620 | SERIES 400 GASTROENTEROLOGY SYSTEM | Apr 27, 1995 | Substantially Equivalent | MARKS & MURASE |
| K944759 | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM | Apr 11, 1995 | Substantially Equivalent | FUJINON, INC. |
| K944254 | OKTAS STEREO VIEWING SYSTEM | Nov 30, 1994 | Substantially Equivalent | OKTAS |
| K944081 | OLYMPUS SWITCHING UNIT MODEL SU-1 | Nov 14, 1994 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | Sep 28, 1994 | Substantially Equivalent | MEDICAL CONCEPTS, INC. |
| K941919 | OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM | Jun 17, 1994 | Substantially Equivalent | OKTAS |
| K942141 | EIDOLON ENDOSCOPE COUPLER | May 27, 1994 | Substantially Equivalent | EIDOLON CORP. |
| K932312 | FUJINON VIDEO LAPAROSCOPE -- MODIFIED | Feb 16, 1994 | Substantially Equivalent | FUJINON, INC. |
| K934918 | EPM-3300 VIDEO PROCESSOR | Feb 07, 1994 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA | Dec 02, 1993 | Substantially Equivalent | ENDOMEDIX |
| K920026 | NOBLES-LAI IMAGING SYSTEM | Jul 28, 1992 | Unknown | NOBLES-LAI ENGINEERING, INC. |
| K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | Sep 27, 1991 | Substantially Equivalent | MEDICAL LASER, INC. |
| K912531 | IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS | Sep 04, 1991 | Substantially Equivalent | INNOVATIVE MEDICAL DEVICES, INC. |
| K911485 | COLOR VIDEO CAMERA | Aug 14, 1991 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Oct 26, 1990 | Substantially Equivalent | PRECISE OPTICS |
| K903458 | PRECISION OPTICS IMAGE COUPLER | Oct 19, 1990 | Substantially Equivalent | PRECISE OPTICS |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Oct 19, 1990 | Substantially Equivalent | PRECISE OPTICS |
| K900380 | MEDILASE 5010 ENDOSCOPE CONSOLE | May 15, 1990 | Substantially Equivalent | MEDICAL LASER, INC. |
| K870680 | OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) | Apr 17, 1987 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K853585 | OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS | Jan 21, 1986 | Substantially Equivalent | OLYMPUS CORP. |
| K843198 | VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y | Oct 04, 1984 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K831412 | CRM-100 COLOR VIDEO CAMERA | Jun 03, 1983 | Substantially Equivalent | UMI, INC. |
| K830924 | CRM-114 COLOR VIDEO CAMERA | Apr 18, 1983 | Substantially Equivalent | UMI, INC. |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | Oct 22, 1982 | Substantially Equivalent | EDER INSTRUMENT CO, INC. |
| K820624 | SYN-OPTICS #5200 | Apr 01, 1982 | Substantially Equivalent | SYN-OPTICS |
| K810393 | ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. | Mar 02, 1981 | Substantially Equivalent | KEYMED, INC. |
FEI Numbers
This FDA classification entry is associated with 79 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 79 registration numbers. Click on an entry to view related FDA registrations.