FDA Product Code
FDA Product Code FET — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 101 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | 2026-09-10 | Traditional | PDF ↗ |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2026-07-02 | Special | PDF ↗ |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026-06-24 | Traditional | PDF ↗ |
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | 2025-09-24 | Traditional | PDF ↗ |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | 2025-08-11 | Traditional | PDF ↗ |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | 2025-07-01 | Traditional | PDF ↗ |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025-04-11 | Traditional | PDF ↗ |
| 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 | Olympus Corporations of the Americas | 2025-04-02 | Traditional | PDF ↗ |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 | Traditional | PDF ↗ |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 | Traditional | PDF ↗ |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | 2024-07-03 | Traditional | PDF ↗ |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | Olympus Medical Systems Corporation | 2023-04-26 | Traditional | PDF ↗ |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022-06-14 | Traditional | PDF ↗ |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022-05-13 | Special | PDF ↗ |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | 2021-10-01 | Traditional | PDF ↗ |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-10-29 | Special | PDF ↗ |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 | Traditional | PDF ↗ |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-07-22 | Special | PDF ↗ |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | Richard Wolf Medical Instruments Corporation | 2020-06-23 | Traditional | PDF ↗ |
| K192286 | FUJIFILM EP-6000 Video Processor | Fujifilm Corporation | 2020-05-01 | Traditional | PDF ↗ |
| K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | 2019-12-20 | Special | PDF ↗ |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Olympus Medical Systems Corp. | 2019-08-30 | Traditional | PDF ↗ |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | 2019-03-29 | Traditional | PDF ↗ |
| K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018-11-20 | Traditional | PDF ↗ |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Richard Wolf Medical Instruments Corporation | 2018-06-28 | Traditional | PDF ↗ |
| K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | 2018-05-24 | Traditional | PDF ↗ |
| K172817 | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA | Olympus Medical Systems Corp. | 2017-10-17 | Special | PDF ↗ |
| K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017-04-25 | Traditional | PDF ↗ |
| K161204 | ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation | 2017-01-11 | Traditional | PDF ↗ |
| K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016-02-01 | Special | PDF ↗ |
| K152109 | HD-Camera HDC1000 | W.O.M. World of Medicine GmbH | 2015-10-13 | Traditional | PDF ↗ |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | Fujifilm Medical System U.S.A., Inc. | 2015-10-01 | Traditional | PDF ↗ |
| K131953 | IMAGE1 SPIES | KARL STORZ Endoscopy-America, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | Richard Wolf Medical Instruments Corp. | 2013-04-03 | Traditional | PDF ↗ |
| K113873 | PENTAX EPK-I5020 VIDEO PROCESSOR | Pentax of America, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K111997 | IMAGE1 GI CCU MODEL 22203020-114 | KARL STORZ Endoscopy-America, Inc. | 2012-04-06 | Traditional | PDF ↗ |
| K102949 | COLONOSCOPY ASSISTANT | Sti Medical Systems, LLC | 2011-06-15 | Traditional | PDF ↗ |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujinon, Inc. | 2011-05-25 | Traditional | PDF ↗ |
| K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | Olympus Medical Systems Corporation | 2010-10-08 | Traditional | PDF ↗ |
| K090800 | VS-100 ILLUMINATION AND IMAGING SYSTEM | Schoelly Imaging, Inc. | 2009-05-18 | Traditional | PDF ↗ |
| K083155 | HD CAMERA HEAD OTV-S7PROH-HD-L08E | Olympus Medical Systems Corporation | 2009-01-13 | Traditional | PDF ↗ |
| K080809 | IEC MEDSIGHT AND MEDBRIGHT | Innovative Endoscopy Components, LLC | 2008-08-11 | Traditional | PDF ↗ |
| K081585 | ENDOSCOPY VIDEO CAMERA SYSTEM | Vision Systems Group, A Division of Viking Systems | 2008-06-20 | Special | PDF ↗ |
| K070716 | IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL | KARL STORZ Endoscopy-America, Inc. | 2007-05-31 | Special | PDF ↗ |
| K043324 | AIDA WITH DICOM AND HL7 INTERFACE | KARL STORZ Endoscopy-America, Inc. | 2005-04-04 | Traditional | PDF ↗ |
| K041494 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 | Olympus Corporation | 2004-07-01 | Special | PDF ↗ |
| K031895 | KSEA OPSERVER LAP | KARL STORZ Endoscopy-America, Inc. | 2003-09-23 | Traditional | PDF ↗ |
| K032544 | VP-1000; MED CAM 100; VP-3000A; MED CAM 300 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | Traditional | PDF ↗ |
| K032545 | ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | Traditional | PDF ↗ |
| K023659 | 1-CCD ENDOCAM 5520 SYSTEM | Richard Wolf Medical Instruments Corp. | 2003-01-29 | Traditional | PDF ↗ |
| K020301 | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | Vista Medical Technologies, Inc. | 2002-02-12 | Special | PDF ↗ |
| K012660 | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES | Gimmi GmbH | 2001-12-20 | Abbreviated | PDF ↗ |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Hill-Rom, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | Karl Storz Imaging, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K003113 | KSEA SCB-RUI SCO | KARL STORZ Endoscopy-America, Inc. | 2001-03-27 | Traditional | PDF ↗ |
| K003710 | DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 | Smith & Nephew, Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K994348 | KSEA SCB-RUI | KARL STORZ Endoscopy-America, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K994090 | KARL STORZ AUTOCLAVABLE CAMERA HEAD | Karl Storz Imaging, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K992469 | KSEA SCBCOM | Karl Storz Endoscopy | 1999-10-15 | Traditional | PDF ↗ |
| K992362 | FLEXISCOPE IQ 101 | Schoelly Fiberoptic GmbH | 1999-08-05 | Traditional | PDF ↗ |
| K981856 | MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) | Greatbatch Scientific | 1998-07-29 | Traditional | PDF ↗ |
| K981827 | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | Angiolaz, Inc. | 1998-07-28 | Traditional | PDF ↗ |
| K973798 | S-357 VIDEO IMAGING SYSTEM | Sopro | 1997-12-03 | Traditional | PDF ↗ |
| K973252 | KARL STORZ DIRECT COUPLED CAMERA HEAD | Karl Storz Imaging, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972540 | S-357 VIDEO IMAGING SYSTEM | Sopro | 1997-09-18 | Traditional | PDF ↗ |
| K971416 | OLYMPUS OES OTV-S5C VIDEO SYSTEM | Olympus America, Inc. | 1997-07-16 | Traditional | PDF ↗ |
| K971373 | VISTA SINGLE CHIP VIDEO CAMERA | Vista Medical Technologies, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K964173 | C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ | Richard Wolf Medical Instruments Corp. | 1996-12-13 | Traditional | PDF ↗ |
| K962024 | S-57 VIDEO IMAGING SYSTEM | Del Medical Systems Corp. | 1996-07-09 | Traditional | PDF ↗ |
| K954451 | EVIS 140 SYSTEM | Olympus America, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K954734 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) | The Tulip Mfg. Co. | 1995-11-14 | Traditional | PDF ↗ |
| K952482 | KSEA REVERSE VIDEO | KARL STORZ Endoscopy-America, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K950417 | EPX-310 VIDEO PROCESSOR (ENDOSCOPY) | Marks & Murase | 1995-07-21 | Traditional | PDF ↗ |
| K950975 | KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS | Karl Storz Imaging, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K950974 | KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS | Karl Storz Imaging, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K944620 | SERIES 400 GASTROENTEROLOGY SYSTEM | Marks & Murase | 1995-04-27 | Traditional | PDF ↗ |
| K944759 | 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM | Fujinon, Inc. | 1995-04-11 | Traditional | PDF ↗ |
| K944254 | OKTAS STEREO VIEWING SYSTEM | Oktas | 1994-11-30 | Traditional | PDF ↗ |
| K944081 | OLYMPUS SWITCHING UNIT MODEL SU-1 | Olympus America, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | Medical Concepts, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K941919 | OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM | Oktas | 1994-06-17 | Traditional | PDF ↗ |
| K942141 | EIDOLON ENDOSCOPE COUPLER | Eidolon Corp. | 1994-05-27 | Traditional | PDF ↗ |
| K932312 | FUJINON VIDEO LAPAROSCOPE -- MODIFIED | Fujinon, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K934918 | EPM-3300 VIDEO PROCESSOR | Pentax Precision Instrument Corp. | 1994-02-07 | Traditional | PDF ↗ |
| K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA | Endomedix | 1993-12-02 | Traditional | PDF ↗ |
| K920026 | NOBLES-LAI IMAGING SYSTEM | Nobles-Lai Engineering, Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | Medical Laser, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K912531 | IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS | Innovative Medical Devices, Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K911485 | COLOR VIDEO CAMERA | United States Endoscopy Group, Inc. | 1991-08-14 | Traditional | PDF ↗ |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Precise Optics | 1990-10-26 | Traditional | PDF ↗ |
| K903458 | PRECISION OPTICS IMAGE COUPLER | Precise Optics | 1990-10-19 | Traditional | PDF ↗ |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Precise Optics | 1990-10-19 | Traditional | PDF ↗ |
| K900380 | MEDILASE 5010 ENDOSCOPE CONSOLE | Medical Laser, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K870680 | OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) | Medline Industries, Inc. | 1987-04-17 | Traditional | PDF ↗ |
| K853585 | OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS | Olympus Corp. | 1986-01-21 | Traditional | PDF ↗ |
| K843198 | VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y | Life-Tech Intl., Inc. | 1984-10-04 | Traditional | PDF ↗ |
| K831412 | CRM-100 COLOR VIDEO CAMERA | Umi, Inc. | 1983-06-03 | Traditional | PDF ↗ |
| K830924 | CRM-114 COLOR VIDEO CAMERA | Umi, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | Eder Instrument Co, Inc. | 1982-10-22 | Traditional | PDF ↗ |
| K820624 | SYN-OPTICS #5200 | Syn-Optics | 1982-04-01 | Traditional | PDF ↗ |
Product code FET · Class II · Gastroenterology, Urology. Data: openFDA.