Ear, Nose, Throat

EOB · Nasopharyngoscope (Flexible Or Rigid)

Ear, Nose, Throat · 21 CFR 874.4760 · Class 2

Overview

Product CodeEOB
Device NameNasopharyngoscope (Flexible Or Rigid)
Regulation21 CFR 874.4760
Device ClassClass 2
Review PanelEar, Nose, Throat
3rd-Party ReviewableYes

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Classification Rationale

Class II.

Cleared Devices (160)

RecordDevice NameApplicantDecision DateDecision
K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.Mar 25, 2026SESE
K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationMar 20, 2026SESE
K241731Outlook Surgical Versa One System (8900139)Resnent, LLCAug 11, 2025SESE
K243639Portare System (FA-001)Grumpy Innovation, Inc.Jun 5, 2025SESE
K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems CorporationMar 3, 2025SESE
K234096MonoStereoMedicaltek Co., Ltd.Sep 19, 2024SESE
K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.Apr 26, 2024SESE
K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)Atmos Medizintechnik GmbH & Co. KGAug 3, 2023SESE
K222587PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc.Jul 28, 2023SESE
K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.Jun 14, 2023SESE
K221660RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPOlympus Medical Systems Corp.Dec 28, 2022SESE
K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.Nov 18, 2022SESE
K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10Pentax of America, Inc.Nov 16, 2022SESE
K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.Sep 19, 2022SESE
K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)Jul 1, 2022SESE
K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.Jun 14, 2022SESE
K202727Peregrine Endoscopy System3nt Medical , Ltd.Jul 23, 2021SESE
K200609ENTity WiFi Video Nasopharyngoscope SystemOptim, LLCJan 13, 2021SESE
K200740HD Video Rhino LaryngoscopeKARL STORZ Endoscopy-America, Inc.Aug 11, 2020SESE
K192305Colibri Endoscopy System3nt Medical , Ltd.Feb 27, 2020SESE
K192090CMOS Video Rhino-Laryngoscope SSUKarl Storz SE & CO. KGJan 27, 2020SESE
K191102Precision S 4K SinuscopeStrykerSep 6, 2019SESE
K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.Sep 6, 2019SESE
K190972Ambu aScope 4 RhinoLaryngo InterventionAmbu A/SJul 12, 2019SESE
K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.Jun 12, 2019SESE
K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/SMay 22, 2019SESE
K182186CMOS Video-Rhino-Laryngoscope SystemKARL STORZ Endoscopy-America, Inc.Mar 22, 2019SESE
K182102RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4Olympus Medical Systems Corp.Feb 6, 2019SESE
K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.Jan 9, 2019SESE
K181286Ambu aScope RLS SlimAmbu A/SNov 30, 2018SESE
K181240Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp.Oct 4, 2018SESE
K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionPentax MedicalJul 18, 2018SESE
K173855Sharpsite AC Rigid EndsocopeMedtronic Xomed, Inc.Apr 20, 2018SESE
K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax MedicalApr 5, 2018SESE
K171402KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc.Feb 2, 2018SESE
K170453Medrobotics Flex Robotic SystemMedrobotics CorporationOct 19, 2017SESE
K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd.Aug 25, 2017SESE
K170285AED SinuscopeNational Advanced Endoscopy Devices, Inc.Aug 1, 2017SESE
K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.Apr 20, 2017SESE
K162410TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.Mar 2, 2017SESE
K1629163NT endoscopy system3nt Medical , Ltd.Feb 24, 2017SESE
K153701ULYSS Multi View SinuscopeSopro-Comeg GmbHSep 9, 2016SESE
K153009ULTRA TelescopesOlympus Winter & Ibe GmbHApr 5, 2016SESE
K152531InstaClear Lens CleanerGyrus Acmi, Inc.Jan 15, 2016SESE
K150776Medrobotics Flex SystemMedrobotics CorporationJul 17, 2015SESE
K143673CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbHMar 4, 2015SESE
K142249SCHOELLY SINUSCOPESchoelly Fiberoptic GmbHJan 27, 2015SESE
K131323ECLERIS SINUSCOPEEcleris USAJun 9, 2014SESE
K132433ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEAcclarent, Inc.Apr 24, 2014SESE
K132009CMOS VIDEO NASOPHARYNGOSCOPE SYSTEMSchoelly Fiberoptic GmbHApr 9, 2014SESE
K103467CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CMKARL STORZ Endoscopy-America, Inc.Jun 28, 2012SESE
K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEAcclarent, Inc.May 27, 2011SESE
K102733VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSORVision-Sciences, Inc.May 18, 2011SESE
K102366FINESS ENDOSCOPEEntellus Medical, Inc.Feb 15, 2011SESE
K100577ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEAcclarent, Inc.Jan 6, 2011SESE
K100125VISION SCIENCES FLEXIBLE ENT SCOPEVision-Sciences, Inc.Feb 25, 2010SESE
K083553NASO-LARYNGO-PHARYNGOSCOPESchoelly Imaging, Inc.Jan 16, 2009SESE
K080740CLEARVIEW ENDOSCOPE COVERInvotec International, Inc.Dec 31, 2008SESE
K082667VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)Visionsense, Ltd.Oct 30, 2008SESE
K082569ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECEEntellus Medical, Inc.Sep 18, 2008SESE
K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105Optim, Inc.Apr 2, 2008SESE
K072387KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIESKARL STORZ Endoscopy-America, Inc.Sep 13, 2007SESE
K072073VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSORVision-Sciences, Inc.Aug 29, 2007SESE
K070580NASOPHARYNGOSCOPE, BRONCHOSCOPEXion GmbHJun 13, 2007SESE
K070752KSEA MINIATURE ENDOSCOPE, MODEL 11565KARL STORZ Endoscopy-America, Inc.May 1, 2007SESE
K063078MICROENDOSCOPEAcclarent, Inc.Oct 24, 2006SESE
K061663ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPESRtc Inc.-Memcath Technologies, LLCSep 6, 2006SESE
K052452VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VTOlympus Medical Systems CorporationSep 21, 2005SESE
K050972VISION-SCIENCES ENT-3000 SCOPEVision-Sciences, Inc.Apr 29, 2005SESE
K040984VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPEVision-Sciences, Inc.Apr 27, 2004SESE
K032822ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0Asap Endoscopic Products GmbHJan 8, 2004SESE
K030857MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIESMahe Intl., Inc.Oct 16, 2003SESE
K031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VOlympus Optical Co., Ltd.Jul 24, 2003SESE
K031790SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTINGVision-Sciences, Inc.Jul 2, 2003SESE
K030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEHenke Sass Wolf of America, Inc.Apr 1, 2003SESE
K023004LFRE INDIRECT LARYNGOSCOPEAstralite Corp.Jan 28, 2003SESE
K024095MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEMVision-Sciences, Inc.Jan 9, 2003SESE
K012543VISION SCIENCES ENDOSHEATH SYSTEMVision-Sciences, Inc.Jul 15, 2002SESE
K021073VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VOlympus America, Inc.May 1, 2002SESE
K020599MTP CLEARVISION DISPOSABLE TUBING SETMtp Medical Technical Promotion GmbHMar 13, 2002SESE
K013838KSEA CLEARVISION LENS IRRIGATION SYSTEMKARL STORZ Endoscopy-America, Inc.Jan 16, 2002SESE
K013591XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENTOlympus Optical Co., Ltd.Dec 26, 2001SESE
K011869XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTThe Olympus Optical Co.Jul 25, 2001SESE
K003830ENT ENDOSCOPESGlobal Endoscopy, Inc.Apr 9, 2001SESE
K002214SINUSCOPE AND BACCESSORIESPollux Endoscopy, Inc.Nov 21, 2000SESE
K002700KSEA UNIMAT 12KARL STORZ Endoscopy-America, Inc.Oct 18, 2000SESE
K992526FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPERichard Wolf Medical Instruments Corp.Sep 24, 1999SESE
K991560NASO-LARYNGO-PHARYNGOSCOPEFiber Imaging Technologies, Inc.Jul 13, 1999SESE
K990354ENDOSHEATHVision-Sciences, Inc.Mar 31, 1999SESE
K990213HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SETGyrus Ent LLCFeb 2, 1999SESE
K984369DCI ENDOSCOPEKARL STORZ Endoscopy-America, Inc.Jan 29, 1999SESE
K983123POC ENT ENDOSCOPE - SINUSCOPEPrecision Optics Corp.Sep 25, 1998SESE
K982594ENDO-SCRUB/ENDO-SCRUB 2Xomed, Inc.Aug 27, 1998SESE
K981751SINUSCOPE AND ACCESSORIESHenke Sass Wolf of America, Inc.Aug 13, 1998SESE
K981458KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110Karl Storz EndoscopyMay 20, 1998SESE
K972450FLEXTIP GRASPEREndius, Inc.Nov 21, 1997SESE
K971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPEWilson Greatbatch Technologies, Inc.Oct 31, 1997SESE
K972855KARL STORZ CONTACT NASAL MICRO-ENDOSCOPESKARL STORZ Endoscopy-America, Inc.Sep 8, 1997SESE
K971995MEDIVISION SINOSCOPEMedivision Scope Service Center, Inc.Jun 26, 1997SESE
K965233SHARPSITE ACXomed, Inc.Apr 4, 1997SESE
K970247SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPESmith & Nephew, Inc.Mar 21, 1997SESE
K962116GALILEO ENDOSCOPESGalileo Electro-Optics Corp.Nov 27, 1996SESE
K963757IRRIGATION/SUCTION HANDLE AND SHEATHRichard Wolf Medical Instruments Corp.Nov 26, 1996SESE
K963426KARL STORZ CONTACT MICRO-LARYNGOSCOPESKARL STORZ Endoscopy-America, Inc.Nov 7, 1996SESE
K962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)Clarus Medical Systems, Inc.Sep 11, 1996SESE
K962898KSEA UNIMAT PLUSKARL STORZ Endoscopy-America, Inc.Aug 27, 1996SESE
K962396KSEA BIPOLAR GOAGULATING FORCEPSKARL STORZ Endoscopy-America, Inc.Aug 27, 1996SESE
K950809VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPESVision-Sciences, Inc.Aug 5, 1996SESE
K961591DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPEVision-Sciences, Inc.Jul 2, 1996SESE
K960876FIVE STAR BRONCHOSCOPEFive Star Medical, Inc.May 8, 1996SESE
K955560TREBAY SCOPE IRRIGATED CLEARING SLEEVETrebay Medical Corp.Dec 22, 1995SESE
K942265FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATHVision-Sciences, Inc.Dec 22, 1995SESE
K953771OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORSKARL STORZ Endoscopy-America, Inc.Nov 22, 1995SESE
K954348GLANZ CARCINOMA GAUGE, KSEAKARL STORZ Endoscopy-America, Inc.Nov 15, 1995SESE
K954336ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)Aust & Taylor Medical Corp.Nov 13, 1995SESE
K953888TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLEVista Medical Technologies, Inc.Oct 7, 1995SESE
K940317SINUSCOPEStephen Chakoff, Inc.May 24, 1995SESE
K951249CITATION SINUSCOPECitation Medical Corp.Apr 10, 1995SESE
K951196FNL-10P, FIBER NASOPARHYNGOSCOPEPentax Precision Instrument Corp.Apr 7, 1995SESE
K951201KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNAREKARL STORZ Endoscopy-America, Inc.Apr 6, 1995SESE
K940028ENDOSCOPE SHEATHXomed-Treace, Inc.Mar 24, 1995SESE
K945081TRANSTYMPANIC ENDOSCOPEEndooptiks, Inc.Mar 6, 1995SESE
K950603KARL STORZ VISCOUS FLUID INJECTION SETKARL STORZ Endoscopy-America, Inc.Feb 27, 1995SESE
K950334KARL STORZ TELE-SCRUBKARL STORZ Endoscopy-America, Inc.Feb 27, 1995SESE
K950338KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPSKARL STORZ Endoscopy-America, Inc.Feb 24, 1995SESE
K944861KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBEKARL STORZ Endoscopy-America, Inc.Feb 21, 1995SESE
K946011ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEMArgus Medical Co., Inc.Feb 17, 1995SESE
K946148KARL STORS KNIVES, CURETTES, HOOKS, NEEDLESKARL STORZ Endoscopy-America, Inc.Feb 9, 1995SESE
K944671VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})Jedmed Instrument Co.Feb 7, 1995SESE
K944670JARIT RECOMMENDED SINUS INSTRUMENTSJ. Jamner Surgical Instruments, Inc.Feb 2, 1995SESE
K944656OPTUS SINUSCOPES AND ACCESSORIESOptus, Inc.Jan 26, 1995SESE
K945788KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURESKARL STORZ Endoscopy-America, Inc.Jan 25, 1995SESE
K945381NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPESKARL STORZ Endoscopy-America, Inc.Jan 18, 1995SESE
K944072OLYMPUS NASAL AND SINUS ENDOSCOPESOlympus America, Inc.Jan 11, 1995SESE
K944797KARL STORZ INSULATED CANNULAE, SUCTION TUBESKARL STORZ Endoscopy-America, Inc.Nov 22, 1994SESE
K944298KARL STORZ INSULATED SCISSORSKARL STORZ Endoscopy-America, Inc.Nov 22, 1994SESE
K944186SINUSCOPEStryker EndoscopyNov 7, 1994SESE
K944296KARL STORZ OPTICAL VIDEO TONGUE DEPRESSORKARL STORZ Endoscopy-America, Inc.Oct 14, 1994SESE
K943665NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTSOlympus America, Inc.Oct 11, 1994SESE
K943816TROCARS,CANNULAE, SHEATHSKarl Storz Endoskop GmbHAug 24, 1994SESE
K943074FORCEPS, PUNCHES, SCISSORSKARL STORZ Endoscopy-America, Inc.Aug 2, 1994SESE
K933672XOMED-TREACE SCOPESHEATHXomed-Treace, Inc.Jul 18, 1994SESE
K941565JARIT RECOMMENDED SINUS INSTRUMENTSJ. Jamner Surgical Instruments, Inc.May 16, 1994SESE
K936257ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3Mitsubishi Cable America, Inc.Mar 24, 1994SESE
K934422NASOPHARYNGOSCOPEMarks & MuraseJan 27, 1994SESE
K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPEXomed-Treace, Inc.Jan 5, 1994SESE
K933247PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOSVision-Sciences, Inc.Nov 22, 1993SESE
K932988ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERYSmith & Nephew Richards, Inc.Jul 26, 1993SESE
K930931NASAL/PARANASAL ENDOSCOPEStorz Instrument Co.May 17, 1993SESE
K925421ENDOSHEATHVision-Sciences, Inc.Jan 15, 1993SESE
K921244DISPOSABLE PROTECTIVE SHEATHVision-Sciences, Inc.Oct 6, 1992SESE
K920439OMEGA OTO NASOPHARYNGO-LARYNGOSCOPEOmega Universal Technologies, Ltd.Sep 4, 1992SESE
K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2Pentax Precision Instrument Corp.Jul 1, 1992SESE
K902683SCOPESCRUBBER(TM)Healthtek Microsurgical, Inc.Oct 31, 1990SESE
K900176ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPESMachida, Inc.Apr 10, 1990SESE
K896297FLEXIBLE NASOPHARYNGOSCOPEJedmed Instrument Co.Jan 26, 1990SESE
K895245FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPEOptimed Technologies, Inc.Nov 17, 1989SESE
K882744EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUMEffner, Inc.Aug 10, 1988SESE
K874215ENDOSCOPES FOR SINUS SURGERYRichards Medical Co., Inc.Jan 4, 1988SESE
K864821AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2Reichert-Jung, Inc.Feb 10, 1987SESE

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