FDA 510(k) Applications for Medical Device Product Code "EOB"
(Nasopharyngoscope (Flexible Or Rigid))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K162916 | 3NT Medical Ltd. | 3NT endoscopy system | 02/24/2017 |
| K192305 | 3NT Medical Ltd. | Colibri Endoscopy System | 02/27/2020 |
| K202727 | 3NT Medical Ltd. | Peregrine Endoscopy System | 07/23/2021 |
| K100577 | ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 01/06/2011 |
| K110097 | ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 05/27/2011 |
| K132433 | ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 04/24/2014 |
| K063078 | ACCLARENT, INC. | MICROENDOSCOPE | 10/24/2006 |
| K190972 | Ambu A/S | Ambu aScope 4 RhinoLaryngo Intervention | 07/12/2019 |
| K191080 | Ambu A/S | Ambu aScope 4 RhinoLaryngo Slim | 05/22/2019 |
| K181286 | Ambu A/S | Ambu aScope RLS Slim | 11/30/2018 |
| K032822 | ASAP ENDOSCOPIC PRODUCTS GMBH | ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 | 01/08/2004 |
| K023004 | ASTRALITE CORP. | LFRE INDIRECT LARYNGOSCOPE | 01/28/2003 |
| K232015 | ATMOS MedizinTechnik GmbH & Co. KG | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | 08/03/2023 |
| K962255 | CLARUS MEDICAL SYSTEMS, INC. | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | 09/11/1996 |
| K131323 | Ecleris USA | ECLERIS SINUSCOPE | 06/09/2014 |
| K972450 | ENDIUS, INC. | FLEXTIP GRASPER | 11/21/1997 |
| K082569 | Entellus Medical, Inc. | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE | 09/18/2008 |
| K102366 | Entellus Medical, Inc. | FINESS ENDOSCOPE | 02/15/2011 |
| K991560 | FIBER IMAGING TECHNOLOGIES, INC. | NASO-LARYNGO-PHARYNGOSCOPE | 07/13/1999 |
| K960876 | FIVE STAR MEDICAL, INC. | FIVE STAR BRONCHOSCOPE | 05/08/1996 |
| K962116 | GALILEO ELECTRO-OPTICS CORP. | GALILEO ENDOSCOPES | 11/27/1996 |
| K003830 | GLOBAL ENDOSCOPY, INC. | ENT ENDOSCOPES | 04/09/2001 |
| K152531 | GYRUS ACMI, INC. | InstaClear Lens Cleaner | 01/15/2016 |
| K990213 | GYRUS ENT L.L.C. | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET | 02/02/1999 |
| K222587 | H&A Mui Enterprises Inc. | PatCom Distal Chip Endoscope | 07/28/2023 |
| K030572 | HENKE SASS WOLF OF AMERICA, INC. | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE | 04/01/2003 |
| K981751 | HENKE SASS WOLF OF AMERICA, INC. | SINUSCOPE AND ACCESSORIES | 08/13/1998 |
| K221581 | Hunan Vathin Medical Instrument Co., Ltd. | Single-Use Flexible Rhinolaryngoscope | 11/18/2022 |
| K230536 | Hunan Vathin Medical Instrument Co., Ltd. | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | 06/14/2023 |
| K080740 | INVOTEC INTERNATIONAL, INC. | CLEARVIEW ENDOSCOPE COVER | 12/31/2008 |
| K981458 | KARL STORZ ENDOSCOPY | KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 | 05/20/1998 |
| K200740 | KARL STORZ Endoscopy - America, Inc. | HD Video Rhino Laryngoscope | 08/11/2020 |
| K162410 | KARL STORZ Endoscopy America, Inc | TIPCAM 1S 3D System | 03/02/2017 |
| K103467 | KARL STORZ ENDOSCOPY-AMERICA, INC. | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM | 06/28/2012 |
| K182186 | KARL STORZ Endoscopy-America, Inc. | CMOS Video-Rhino-Laryngoscope System | 03/22/2019 |
| K984369 | KARL STORZ ENDOSCOPY-AMERICA, INC. | DCI ENDOSCOPE | 01/29/1999 |
| K963426 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ CONTACT MICRO-LARYNGOSCOPES | 11/07/1996 |
| K972855 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES | 09/08/1997 |
| K171402 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ Slim Nasopharyngolaryngoscope | 02/02/2018 |
| K072387 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES | 09/13/2007 |
| K962396 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA BIPOLAR GOAGULATING FORCEPS | 08/27/1996 |
| K013838 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA CLEARVISION LENS IRRIGATION SYSTEM | 01/16/2002 |
| K070752 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA MINIATURE ENDOSCOPE, MODEL 11565 | 05/01/2007 |
| K002700 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIMAT 12 | 10/18/2000 |
| K962898 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIMAT PLUS | 08/27/1996 |
| K192090 | Karl Storz SE & Co. KG | CMOS Video Rhino-Laryngoscope SSU | 01/27/2020 |
| K030857 | MAHE INTL., INC. | MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES | 10/16/2003 |
| K214050 | Medimaging Integrated Solution Inc. (MiiS) | ENT Nasopharyngoscope and Accessories | 07/01/2022 |
| K971995 | MEDIVISION SCOPE SERVICE CENTER, INC. | MEDIVISION SINOSCOPE | 06/26/1997 |
| K170453 | Medrobotics Corporation | Medrobotics Flex Robotic System | 10/19/2017 |
| K150776 | MEDROBOTICS CORPORATION | Medrobotics Flex System | 07/17/2015 |
| K173855 | Medtronic Xomed Inc. | Sharpsite AC Rigid Endsocope | 04/20/2018 |
| K020599 | MTP MEDICAL TECHNICAL PROMOTION GMBH | MTP CLEARVISION DISPOSABLE TUBING SET | 03/13/2002 |
| K170285 | National Advanced Endoscopy Devices, Inc. | AED Sinuscope | 08/01/2017 |
| K021073 | OLYMPUS AMERICA, INC. | VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | 05/01/2002 |
| K181240 | Olympus Medical Systems Corp. | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | 10/04/2018 |
| K221638 | Olympus Medical Systems Corp. | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | 09/19/2022 |
| K182102 | Olympus Medical Systems Corp. | RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 | 02/06/2019 |
| K183416 | Olympus Medical Systems Corp. | Rhino-Laryngo Videoscope Olympus ENF-VT3 | 09/06/2019 |
| K221660 | Olympus Medical Systems Corp. | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | 12/28/2022 |
| K052452 | OLYMPUS MEDICAL SYSTEMS CORPORATION | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT | 09/21/2005 |
| K031648 | OLYMPUS OPTICAL CO., LTD. | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | 07/24/2003 |
| K013591 | OLYMPUS OPTICAL CO., LTD. | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | 12/26/2001 |
| K153009 | OLYMPUS, WINTER & IBE GMBH | ULTRA Telescopes | 04/05/2016 |
| K080622 | OPTIM, INC. | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | 04/02/2008 |
| K200609 | Optim, LLC | ENTity WiFi Video Nasopharyngoscope System | 01/13/2021 |
| K172156 | Pentax Medical | PENTAX Medical EPK-3000 Video Imaging System | 04/05/2018 |
| K171011 | Pentax Medical | PENTAX Medical VIVIDEO ENT Videoscope Solution | 07/18/2018 |
| K162151 | PENTAX OF AMERICA, INC. | PENTAX Medical ENT Video Imaging System | 04/20/2017 |
| K183691 | PENTAX of America, Inc. | PENTAX Medical ENT Video Imaging System | 06/12/2019 |
| K220465 | PENTAX of America, Inc. | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | 11/16/2022 |
| K182846 | PENTAX of America, Inc. | PENTAX Medical EPK-3000 Video Imaging System | 01/09/2019 |
| K002214 | POLLUX ENDOSCOPY, INC. | SINUSCOPE AND BACCESSORIES | 11/21/2000 |
| K983123 | PRECISION OPTICS CORP. | POC ENT ENDOSCOPE - SINUSCOPE | 09/25/1998 |
| K992526 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE | 09/24/1999 |
| K963757 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | IRRIGATION/SUCTION HANDLE AND SHEATH | 11/26/1996 |
| K061663 | RTC INC.-MEMCATH TECHNOLOGIES LLC | ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES | 09/06/2006 |
| K143673 | Schoelly Fiberoptic Gmbh | CMOS Video Nasopharyngoscope System | 03/04/2015 |
| K142249 | SCHOELLY FIBEROPTIC GMBH | SCHOELLY SINUSCOPE | 01/27/2015 |
| K132009 | SCHOELLY FIBEROPTIC, GMBH | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM | 04/09/2014 |
| K083553 | SCHOELLY IMAGING, INC. | NASO-LARYNGO-PHARYNGOSCOPE | 01/16/2009 |
| K161298 | SHENYANG SHENDA ENDOSCOPE CO., LTD | ShenDa Sinuscope | 08/25/2017 |
| K970247 | SMITH & NEPHEW, INC. | SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE | 03/21/1997 |
| K153701 | SOPRO-COMEG GMBH | ULYSS Multi View Sinuscope | 09/09/2016 |
| K191102 | Stryker | Precision S 4K Sinuscope | 09/06/2019 |
| K011869 | THE OLYMPUS OPTICAL CO. | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | 07/25/2001 |
| K961591 | VISION-SCIENCES, INC. | DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE | 07/02/1996 |
| K990354 | VISION-SCIENCES, INC. | ENDOSHEATH | 03/31/1999 |
| K024095 | VISION-SCIENCES, INC. | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM | 01/09/2003 |
| K031790 | VISION-SCIENCES, INC. | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING | 07/02/2003 |
| K012543 | VISION-SCIENCES, INC. | VISION SCIENCES ENDOSHEATH SYSTEM | 07/15/2002 |
| K100125 | VISION-SCIENCES, INC. | VISION SCIENCES FLEXIBLE ENT SCOPE | 02/25/2010 |
| K040984 | VISION-SCIENCES, INC. | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE | 04/27/2004 |
| K950809 | VISION-SCIENCES, INC. | VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES | 08/05/1996 |
| K050972 | VISION-SCIENCES, INC. | VISION-SCIENCES ENT-3000 SCOPE | 04/29/2005 |
| K072073 | VISION-SCIENCES, INC. | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR | 08/29/2007 |
| K102733 | VISION-SCIENCES, INC. | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR | 05/18/2011 |
| K082667 | VISIONSENSE, LTD. | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) | 10/30/2008 |
| K971375 | WILSON GREATBATCH TECHNOLOGIES, INC. | GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE | 10/31/1997 |
| K070580 | XION GMBH | NASOPHARYNGOSCOPE, BRONCHOSCOPE | 06/13/2007 |
| K982594 | XOMED, INC. | ENDO-SCRUB/ENDO-SCRUB 2 | 08/27/1998 |
| K965233 | XOMED, INC. | SHARPSITE AC | 04/04/1997 |
| K220004 | Zsquare, Ltd | Zsquare ENT-Flex Endoscope | 06/14/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
