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
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
K181286 Ambu A/S Ambu aScope RLS Slim 11/30/2018
K946011 ARGUS MEDICAL CO., INC. ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM 02/17/1995
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
K954336 AUST & TAYLOR MEDICAL CORP. ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE) 11/13/1995
K951249 CITATION MEDICAL CORP. CITATION SINUSCOPE 04/10/1995
K962255 CLARUS MEDICAL SYSTEMS, INC. CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) 09/11/1996
K131323 Ecleris USA ECLERIS SINUSCOPE 06/09/2014
K882744 EFFNER, INC. EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM 08/10/1988
K972450 ENDIUS, INC. FLEXTIP GRASPER 11/21/1997
K945081 ENDO OPTIKS, INC. TRANSTYMPANIC ENDOSCOPE 03/06/1995
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
K902683 HEALTHTEK MICROSURGICAL, INC. SCOPESCRUBBER(TM) 10/31/1990
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
K080740 INVOTEC INTERNATIONAL, INC. CLEARVIEW ENDOSCOPE COVER 12/31/2008
K941565 J. JAMNER SURGICAL INSTRUMENTS, INC. JARIT RECOMMENDED SINUS INSTRUMENTS 05/16/1994
K944670 J. JAMNER SURGICAL INSTRUMENTS, INC. JARIT RECOMMENDED SINUS INSTRUMENTS 02/02/1995
K896297 JEDMED INSTRUMENT CO. FLEXIBLE NASOPHARYNGOSCOPE 01/26/1990
K944671 JEDMED INSTRUMENT CO. VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) 02/07/1995
K981458 KARL STORZ ENDOSCOPY KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 05/20/1998
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
K984369 KARL STORZ ENDOSCOPY-AMERICA, INC. DCI ENDOSCOPE 01/29/1999
K943074 KARL STORZ ENDOSCOPY-AMERICA, INC. FORCEPS, PUNCHES, SCISSORS 08/02/1994
K954348 KARL STORZ ENDOSCOPY-AMERICA, INC. GLANZ CARCINOMA GAUGE, KSEA 11/15/1995
K946148 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES 02/09/1995
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
K944797 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ INSULATED CANNULAE, SUCTION TUBES 11/22/1994
K944298 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ INSULATED SCISSORS 11/22/1994
K944861 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE 02/21/1995
K951201 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE 04/06/1995
K944296 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR 10/14/1994
K950338 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS 02/24/1995
K945788 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES 01/25/1995
K171402 KARL STORZ Endoscopy-America, Inc. KARL STORZ Slim Nasopharyngolaryngoscope 02/02/2018
K950334 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ TELE-SCRUB 02/27/1995
K072387 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES 09/13/2007
K950603 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ VISCOUS FLUID INJECTION SET 02/27/1995
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
K945381 KARL STORZ ENDOSCOPY-AMERICA, INC. NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES 01/18/1995
K953771 KARL STORZ ENDOSCOPY-AMERICA, INC. OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS 11/22/1995
K943816 KARL STORZ ENDOSKOP GMBH TROCARS,CANNULAE, SHEATHS 08/24/1994
K900176 MACHIDA, INC. ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES 04/10/1990
K030857 MAHE INTL., INC. MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES 10/16/2003
K934422 MARKS & MURASE NASOPHARYNGOSCOPE 01/27/1994
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
K936257 MITSUBISHI CABLE AMERICA, INC. ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3 03/24/1994
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
K943665 OLYMPUS AMERICA, INC. NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS 10/11/1994
K944072 OLYMPUS AMERICA, INC. OLYMPUS NASAL AND SINUS ENDOSCOPES 01/11/1995
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
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
K920439 OMEGA UNIVERSAL TECHNOLOGIES, LTD. OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE 09/04/1992
K080622 OPTIM, INC. ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 04/02/2008
K895245 OPTIMED TECHNOLOGIES, INC. FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE 11/17/1989
K944656 OPTUS, INC. OPTUS SINUSCOPES AND ACCESSORIES 01/26/1995
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
K182846 PENTAX of America, Inc. PENTAX Medical EPK-3000 Video Imaging System 01/09/2019
K951196 PENTAX PRECISION INSTRUMENT CORP. FNL-10P, FIBER NASOPARHYNGOSCOPE 04/07/1995
K921707 PENTAX PRECISION INSTRUMENT CORP. PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 07/01/1992
K002214 POLLUX ENDOSCOPY, INC. SINUSCOPE AND BACCESSORIES 11/21/2000
K983123 PRECISION OPTICS CORP. POC ENT ENDOSCOPE - SINUSCOPE 09/25/1998
K864821 REICHERT-JUNG, INC. AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 02/10/1987
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
K874215 RICHARDS MEDICAL CO., INC. ENDOSCOPES FOR SINUS SURGERY 01/04/1988
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
K932988 SMITH & NEPHEW RICHARDS, INC. ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY 07/26/1993
K970247 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE 03/21/1997
K153701 SOPRO-COMEG GMBH ULYSS Multi View Sinuscope 09/09/2016
K940317 STEPHEN CHAKOFF, INC. SINUSCOPE 05/24/1995
K930931 STORZ INSTRUMENT CO. NASAL/PARANASAL ENDOSCOPE 05/17/1993
K944186 STRYKER ENDOSCOPY SINUSCOPE 11/07/1994
K011869 THE OLYMPUS OPTICAL CO. XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT 07/25/2001
K955560 TREBAY MEDICAL CORP. TREBAY SCOPE IRRIGATED CLEARING SLEEVE 12/22/1995
K961591 VISION-SCIENCES, INC. DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE 07/02/1996
K921244 VISION-SCIENCES, INC. DISPOSABLE PROTECTIVE SHEATH 10/06/1992
K925421 VISION-SCIENCES, INC. ENDOSHEATH 01/15/1993
K990354 VISION-SCIENCES, INC. ENDOSHEATH 03/31/1999
K942265 VISION-SCIENCES, INC. FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH 12/22/1995
K024095 VISION-SCIENCES, INC. MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM 01/09/2003
K933247 VISION-SCIENCES, INC. PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS 11/22/1993
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
K953888 VISTA MEDICAL TECHNOLOGIES, INC. TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE 10/07/1995
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
K940028 XOMED-TREACE, INC. ENDOSCOPE SHEATH 03/24/1995
K933105 XOMED-TREACE, INC. XOMED-TREACE RIGID ROD LENS ENDOSCOPE 01/05/1994
K933672 XOMED-TREACE, INC. XOMED-TREACE SCOPESHEATH 07/18/1994


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