Atlas FDA

EOB

162 FDA 510(k) clearances · Product code

94 daysmedian time to decision
282 days90th percentile
162clearances measured

FDA profile

Official device name
Nasopharyngoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4760
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 345 · 2022: 1,158 · 2023: 1,352 · 2024: 1,498 · 2025: 1,356 · 2026: 1,783
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Hydro Irrigation System (K261544)Stryker Instruments2026-06-17
ENTity USB Videoscope System (K254133)Optim, LLC2026-05-14
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (K253184)Zhuhai Wesee Meditech Co., Ltd.2026-03-25
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (K252050)Olympus Medical Systems Corporation2026-03-20
Outlook Surgical Versa One System (8900139) (K241731)Resnent, LLC2025-08-11
Portare System (FA-001) (K243639)Grumpy Innovation, Inc.2025-06-05
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K243380)Olympus Medical Systems Corporation2025-03-03
MonoStereo (K234096)Medicaltek Co., Ltd.2024-09-19
Rhinolaryngoscope system (K232435)Shenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-26
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) (K232015)Atmos Medizintechnik GmbH & Co. KG2023-08-03
PatCom Distal Chip Endoscope (K222587)H&A Mui Enterprises, Inc.2023-07-28
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (K230536)Hunan Vathin Medical Instrument Co., Ltd.2023-06-14
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (K221660)Olympus Medical Systems Corp.2022-12-28
Single-Use Flexible Rhinolaryngoscope (K221581)Hunan Vathin Medical Instrument Co., Ltd.2022-11-18
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 (K220465)Pentax of America, Inc.2022-11-16
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 (K221638)Olympus Medical Systems Corp.2022-09-19
ENT Nasopharyngoscope and Accessories (K214050)Medimaging Integrated Solution, Inc (Miis)2022-07-01
Zsquare ENT-Flex Endoscope (K220004)Zsquare, Ltd.2022-06-14
Peregrine Endoscopy System (K202727)3nt Medical , Ltd.2021-07-23
ENTity WiFi Video Nasopharyngoscope System (K200609)Optim, LLC2021-01-13
HD Video Rhino Laryngoscope (K200740)KARL STORZ Endoscopy-America, Inc.2020-08-11
Colibri Endoscopy System (K192305)3nt Medical , Ltd.2020-02-27
CMOS Video Rhino-Laryngoscope SSU (K192090)Karl Storz SE & CO. KG2020-01-27
Precision S 4K Sinuscope (K191102)Stryker2019-09-06
Rhino-Laryngo Videoscope Olympus ENF-VT3 (K183416)Olympus Medical Systems Corp.2019-09-06
Ambu aScope 4 RhinoLaryngo Intervention (K190972)Ambu A/S2019-07-12
PENTAX Medical ENT Video Imaging System (K183691)Pentax of America, Inc.2019-06-12
Ambu aScope 4 RhinoLaryngo Slim (K191080)Ambu A/S2019-05-22
CMOS Video-Rhino-Laryngoscope System (K182186)KARL STORZ Endoscopy-America, Inc.2019-03-22
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (K182102)Olympus Medical Systems Corp.2019-02-06
PENTAX Medical EPK-3000 Video Imaging System (K182846)Pentax of America, Inc.2019-01-09
Ambu aScope RLS Slim (K181286)Ambu A/S2018-11-30
Rhino-Laryngo Fiberscope Olympus ENF-GP2 (K181240)Olympus Medical Systems Corp.2018-10-04
PENTAX Medical VIVIDEO ENT Videoscope Solution (K171011)Pentax Medical2018-07-18
Sharpsite AC Rigid Endsocope (K173855)Medtronic Xomed, Inc.2018-04-20
PENTAX Medical EPK-3000 Video Imaging System (K172156)Pentax Medical2018-04-05
KARL STORZ Slim Nasopharyngolaryngoscope (K171402)KARL STORZ Endoscopy-America, Inc.2018-02-02
Medrobotics Flex Robotic System (K170453)Medrobotics Corporation2017-10-19
ShenDa Sinuscope (K161298)Shenyang Shenda Endoscope Co., Ltd.2017-08-25
AED Sinuscope (K170285)National Advanced Endoscopy Devices, Inc.2017-08-01
PENTAX Medical ENT Video Imaging System (K162151)Pentax of America, Inc.2017-04-20
TIPCAM 1S 3D System (K162410)Karl Storz Endoscopy America, Inc.2017-03-02
3NT endoscopy system (K162916)3nt Medical , Ltd.2017-02-24
ULYSS Multi View Sinuscope (K153701)Sopro-Comeg GmbH2016-09-09
ULTRA Telescopes (K153009)Olympus Winter & Ibe GmbH2016-04-05
InstaClear Lens Cleaner (K152531)Gyrus Acmi, Inc.2016-01-15
Medrobotics Flex System (K150776)Medrobotics Corporation2015-07-17
CMOS Video Nasopharyngoscope System (K143673)Schoelly Fiberoptic GmbH2015-03-04
SCHOELLY SINUSCOPE (K142249)Schoelly Fiberoptic GmbH2015-01-27
ECLERIS SINUSCOPE (K131323)Ecleris USA2014-06-09
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K132433)Acclarent, Inc.2014-04-24
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM (K132009)Schoelly Fiberoptic GmbH2014-04-09
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM (K103467)KARL STORZ Endoscopy-America, Inc.2012-06-28
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K110097)Acclarent, Inc.2011-05-27
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR (K102733)Vision-Sciences, Inc.2011-05-18
FINESS ENDOSCOPE (K102366)Entellus Medical, Inc.2011-02-15
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K100577)Acclarent, Inc.2011-01-06
VISION SCIENCES FLEXIBLE ENT SCOPE (K100125)Vision-Sciences, Inc.2010-02-25
NASO-LARYNGO-PHARYNGOSCOPE (K083553)Schoelly Imaging, Inc.2009-01-16
CLEARVIEW ENDOSCOPE COVER (K080740)Invotec International, Inc.2008-12-31
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (K082667)Visionsense, Ltd.2008-10-30
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE (K082569)Entellus Medical, Inc.2008-09-18
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (K080622)Optim, Inc.2008-04-02
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES (K072387)KARL STORZ Endoscopy-America, Inc.2007-09-13
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR (K072073)Vision-Sciences, Inc.2007-08-29
NASOPHARYNGOSCOPE, BRONCHOSCOPE (K070580)Xion GmbH2007-06-13
KSEA MINIATURE ENDOSCOPE, MODEL 11565 (K070752)KARL STORZ Endoscopy-America, Inc.2007-05-01
MICROENDOSCOPE (K063078)Acclarent, Inc.2006-10-24
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES (K061663)Rtc Inc.-Memcath Technologies, LLC2006-09-06
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT (K052452)Olympus Medical Systems Corporation2005-09-21
VISION-SCIENCES ENT-3000 SCOPE (K050972)Vision-Sciences, Inc.2005-04-29
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE (K040984)Vision-Sciences, Inc.2004-04-27
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 (K032822)Asap Endoscopic Products GmbH2004-01-08
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES (K030857)Mahe Intl., Inc.2003-10-16
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K031648)Olympus Optical Co., Ltd.2003-07-24
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING (K031790)Vision-Sciences, Inc.2003-07-02
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE (K030572)Henke Sass Wolf of America, Inc.2003-04-01
LFRE INDIRECT LARYNGOSCOPE (K023004)Astralite Corp.2003-01-28
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM (K024095)Vision-Sciences, Inc.2003-01-09
VISION SCIENCES ENDOSHEATH SYSTEM (K012543)Vision-Sciences, Inc.2002-07-15
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K021073)Olympus America, Inc.2002-05-01
MTP CLEARVISION DISPOSABLE TUBING SET (K020599)Mtp Medical Technical Promotion GmbH2002-03-13
KSEA CLEARVISION LENS IRRIGATION SYSTEM (K013838)KARL STORZ Endoscopy-America, Inc.2002-01-16
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT (K013591)Olympus Optical Co., Ltd.2001-12-26
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K011869)The Olympus Optical Co.2001-07-25
ENT ENDOSCOPES (K003830)Global Endoscopy, Inc.2001-04-09
SINUSCOPE AND BACCESSORIES (K002214)Pollux Endoscopy, Inc.2000-11-21
KSEA UNIMAT 12 (K002700)KARL STORZ Endoscopy-America, Inc.2000-10-18
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE (K992526)Richard Wolf Medical Instruments Corp.1999-09-24
NASO-LARYNGO-PHARYNGOSCOPE (K991560)Fiber Imaging Technologies, Inc.1999-07-13
ENDOSHEATH (K990354)Vision-Sciences, Inc.1999-03-31
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET (K990213)Gyrus Ent LLC1999-02-02
DCI ENDOSCOPE (K984369)KARL STORZ Endoscopy-America, Inc.1999-01-29
POC ENT ENDOSCOPE - SINUSCOPE (K983123)Precision Optics Corp.1998-09-25
ENDO-SCRUB/ENDO-SCRUB 2 (K982594)Xomed, Inc.1998-08-27
SINUSCOPE AND ACCESSORIES (K981751)Henke Sass Wolf of America, Inc.1998-08-13
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 (K981458)Karl Storz Endoscopy1998-05-20
FLEXTIP GRASPER (K972450)Endius, Inc.1997-11-21
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE (K971375)Wilson Greatbatch Technologies, Inc.1997-10-31
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES (K972855)KARL STORZ Endoscopy-America, Inc.1997-09-08
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