FDA Product Code
FDA Product Code EOB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4760
510(k) Clearances — 163 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | 2026-09-15 | Traditional | PDF ↗ |
| K261544 | Hydro Irrigation System | Stryker Instruments | 2026-06-17 | Traditional | PDF ↗ |
| K254133 | ENTity USB Videoscope System | Optim, LLC | 2026-05-14 | Traditional | PDF ↗ |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | 2026-03-25 | Traditional | PDF ↗ |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | 2026-03-20 | Traditional | PDF ↗ |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025-08-11 | Traditional | PDF ↗ |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | 2025-03-03 | Traditional | PDF ↗ |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | 2024-09-19 | Traditional | PDF ↗ |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 | Traditional | PDF ↗ |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG | 2023-08-03 | Traditional | PDF ↗ |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 | Traditional | PDF ↗ |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | 2022-12-28 | Traditional | PDF ↗ |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | Pentax of America, Inc. | 2022-11-16 | Traditional | PDF ↗ |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | Olympus Medical Systems Corp. | 2022-09-19 | Traditional | PDF ↗ |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | 2022-07-01 | Traditional | PDF ↗ |
| K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022-06-14 | Traditional | PDF ↗ |
| K202727 | Peregrine Endoscopy System | 3nt Medical , Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | 2021-01-13 | Traditional | PDF ↗ |
| K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | 2020-08-11 | Traditional | PDF ↗ |
| K192305 | Colibri Endoscopy System | 3nt Medical , Ltd. | 2020-02-27 | Special | PDF ↗ |
| K192090 | CMOS Video Rhino-Laryngoscope SSU | Karl Storz SE & CO. KG | 2020-01-27 | Traditional | PDF ↗ |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | Olympus Medical Systems Corp. | 2019-09-06 | Traditional | PDF ↗ |
| K191102 | Precision S 4K Sinuscope | Stryker | 2019-09-06 | Traditional | PDF ↗ |
| K190972 | Ambu aScope 4 RhinoLaryngo Intervention | Ambu A/S | 2019-07-12 | Traditional | PDF ↗ |
| K183691 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2019-06-12 | Special | PDF ↗ |
| K191080 | Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S | 2019-05-22 | Special | PDF ↗ |
| K182186 | CMOS Video-Rhino-Laryngoscope System | KARL STORZ Endoscopy-America, Inc. | 2019-03-22 | Traditional | PDF ↗ |
| K182102 | RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 | Olympus Medical Systems Corp. | 2019-02-06 | Traditional | PDF ↗ |
| K182846 | PENTAX Medical EPK-3000 Video Imaging System | Pentax of America, Inc. | 2019-01-09 | Special | PDF ↗ |
| K181286 | Ambu aScope RLS Slim | Ambu A/S | 2018-11-30 | Traditional | PDF ↗ |
| K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | Olympus Medical Systems Corp. | 2018-10-04 | Traditional | PDF ↗ |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | Pentax Medical | 2018-07-18 | Traditional | PDF ↗ |
| K173855 | Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | Pentax Medical | 2018-04-05 | Traditional | PDF ↗ |
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018-02-02 | Traditional | PDF ↗ |
| K170453 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017-10-19 | Traditional | PDF ↗ |
| K161298 | ShenDa Sinuscope | Shenyang Shenda Endoscope Co., Ltd. | 2017-08-25 | Traditional | PDF ↗ |
| K170285 | AED Sinuscope | National Advanced Endoscopy Devices, Inc. | 2017-08-01 | Traditional | PDF ↗ |
| K162151 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2017-04-20 | Traditional | PDF ↗ |
| K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K162916 | 3NT endoscopy system | 3nt Medical , Ltd. | 2017-02-24 | Traditional | PDF ↗ |
| K153701 | ULYSS Multi View Sinuscope | Sopro-Comeg GmbH | 2016-09-09 | Traditional | PDF ↗ |
| K153009 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016-04-05 | Traditional | PDF ↗ |
| K152531 | InstaClear Lens Cleaner | Gyrus Acmi, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K150776 | Medrobotics Flex System | Medrobotics Corporation | 2015-07-17 | Traditional | PDF ↗ |
| K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2015-03-04 | Special | PDF ↗ |
| K142249 | SCHOELLY SINUSCOPE | Schoelly Fiberoptic GmbH | 2015-01-27 | Traditional | PDF ↗ |
| K131323 | ECLERIS SINUSCOPE | Ecleris USA | 2014-06-09 | Traditional | PDF ↗ |
| K132433 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2014-04-24 | Traditional | PDF ↗ |
| K132009 | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM | Schoelly Fiberoptic GmbH | 2014-04-09 | Traditional | PDF ↗ |
| K103467 | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM | KARL STORZ Endoscopy-America, Inc. | 2012-06-28 | Special | PDF ↗ |
| K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2011-05-27 | Special | PDF ↗ |
| K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR | Vision-Sciences, Inc. | 2011-05-18 | Traditional | PDF ↗ |
| K102366 | FINESS ENDOSCOPE | Entellus Medical, Inc. | 2011-02-15 | Traditional | PDF ↗ |
| K100577 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | Acclarent, Inc. | 2011-01-06 | Traditional | PDF ↗ |
| K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE | Vision-Sciences, Inc. | 2010-02-25 | Special | PDF ↗ |
| K083553 | NASO-LARYNGO-PHARYNGOSCOPE | Schoelly Imaging, Inc. | 2009-01-16 | Special | PDF ↗ |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Invotec International, Inc. | 2008-12-31 | Traditional | PDF ↗ |
| K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) | Visionsense, Ltd. | 2008-10-30 | Traditional | PDF ↗ |
| K082569 | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE | Entellus Medical, Inc. | 2008-09-18 | Traditional | PDF ↗ |
| K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | Optim, Inc. | 2008-04-02 | Special | PDF ↗ |
| K072387 | KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES | KARL STORZ Endoscopy-America, Inc. | 2007-09-13 | Traditional | PDF ↗ |
| K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR | Vision-Sciences, Inc. | 2007-08-29 | Special | PDF ↗ |
| K070580 | NASOPHARYNGOSCOPE, BRONCHOSCOPE | Xion GmbH | 2007-06-13 | Traditional | PDF ↗ |
| K070752 | KSEA MINIATURE ENDOSCOPE, MODEL 11565 | KARL STORZ Endoscopy-America, Inc. | 2007-05-01 | Traditional | PDF ↗ |
| K063078 | MICROENDOSCOPE | Acclarent, Inc. | 2006-10-24 | Traditional | PDF ↗ |
| K061663 | ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES | Rtc Inc.-Memcath Technologies, LLC | 2006-09-06 | Traditional | PDF ↗ |
| K052452 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT | Olympus Medical Systems Corporation | 2005-09-21 | Traditional | PDF ↗ |
| K050972 | VISION-SCIENCES ENT-3000 SCOPE | Vision-Sciences, Inc. | 2005-04-29 | Special | PDF ↗ |
| K040984 | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE | Vision-Sciences, Inc. | 2004-04-27 | Special | PDF ↗ |
| K032822 | 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 | Asap Endoscopic Products GmbH | 2004-01-08 | Traditional | PDF ↗ |
| K030857 | MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES | Mahe Intl., Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | Olympus Optical Co., Ltd. | 2003-07-24 | Traditional | PDF ↗ |
| K031790 | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING | Vision-Sciences, Inc. | 2003-07-02 | Traditional | PDF ↗ |
| K030572 | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE | Henke Sass Wolf of America, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K023004 | LFRE INDIRECT LARYNGOSCOPE | Astralite Corp. | 2003-01-28 | Traditional | PDF ↗ |
| K024095 | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2003-01-09 | Special | PDF ↗ |
| K012543 | VISION SCIENCES ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2002-07-15 | Traditional | PDF ↗ |
| K021073 | VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | Olympus America, Inc. | 2002-05-01 | Special | PDF ↗ |
| K020599 | MTP CLEARVISION DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 2002-03-13 | Traditional | PDF ↗ |
| K013838 | KSEA CLEARVISION LENS IRRIGATION SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2002-01-16 | Traditional | PDF ↗ |
| K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | Olympus Optical Co., Ltd. | 2001-12-26 | Traditional | PDF ↗ |
| K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | The Olympus Optical Co. | 2001-07-25 | Traditional | PDF ↗ |
| K003830 | ENT ENDOSCOPES | Global Endoscopy, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K002214 | SINUSCOPE AND BACCESSORIES | Pollux Endoscopy, Inc. | 2000-11-21 | Traditional | PDF ↗ |
| K002700 | KSEA UNIMAT 12 | KARL STORZ Endoscopy-America, Inc. | 2000-10-18 | Traditional | PDF ↗ |
| K992526 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE | Richard Wolf Medical Instruments Corp. | 1999-09-24 | Traditional | PDF ↗ |
| K991560 | NASO-LARYNGO-PHARYNGOSCOPE | Fiber Imaging Technologies, Inc. | 1999-07-13 | Traditional | PDF ↗ |
| K990354 | ENDOSHEATH | Vision-Sciences, Inc. | 1999-03-31 | Special | PDF ↗ |
| K990213 | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET | Gyrus Ent LLC | 1999-02-02 | Special | PDF ↗ |
| K984369 | DCI ENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K983123 | POC ENT ENDOSCOPE - SINUSCOPE | Precision Optics Corp. | 1998-09-25 | Traditional | PDF ↗ |
| K982594 | ENDO-SCRUB/ENDO-SCRUB 2 | Xomed, Inc. | 1998-08-27 | Traditional | PDF ↗ |
| K981751 | SINUSCOPE AND ACCESSORIES | Henke Sass Wolf of America, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K981458 | KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 | Karl Storz Endoscopy | 1998-05-20 | Traditional | PDF ↗ |
| K972450 | FLEXTIP GRASPER | Endius, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K971375 | GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE | Wilson Greatbatch Technologies, Inc. | 1997-10-31 | Traditional | PDF ↗ |
Product code EOB · Class II · Ear, Nose, Throat. Data: openFDA.