Panels › Ear, Nose, Throat › Product code EOB · Class 2
Nasopharyngoscope (Flexible Or Rigid)
Regulation 874.4760
5510(k)s in 12 months (163 all time)
1recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in EOB
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 | 0 |
| Vision-Sciences, Inc. | 15 | 2 |
| Olympus Medical Systems Corp. | 8 | 0 |
| Acclarent, Inc. | 4 | 0 |
| Pentax of America, Inc. | 4 | 0 |
| 3nt Medical , Ltd. | 3 | 0 |
| Ambu A/S | 3 | 0 |
| Karl Storz Endoscopy | 1 | 2 |
| Olympus America, Inc. | 3 | 0 |
| Olympus Corporation of the Americas | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2014 | K131323 | ECLERIS SINUSCOPE Ecleris USA | EOB |
| Apr 24, 2014 | K132433 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| Apr 9, 2014 | K132009 | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM Schoelly Fiberoptic GmbH | EOB |
| Jun 28, 2012 | K103467 | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM KARL STORZ Endoscopy-America, Inc. | EOB |
| May 27, 2011 | K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| May 18, 2011 | K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. | EOB |
| Feb 15, 2011 | K102366 | FINESS ENDOSCOPE Entellus Medical, Inc. | EOB |
| Jan 6, 2011 | K100577 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| Feb 25, 2010 | K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE Vision-Sciences, Inc. | EOB |
| Jan 16, 2009 | K083553 | NASO-LARYNGO-PHARYNGOSCOPE Schoelly Imaging, Inc. | EOB |
| Dec 31, 2008 | K080740 | CLEARVIEW ENDOSCOPE COVER Invotec International, Inc. | EOB |
| Oct 30, 2008 | K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) Visionsense, Ltd. | EOB |
| Sep 18, 2008 | K082569 | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE Entellus Medical, Inc. | EOB |
| Apr 2, 2008 | K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 Optim, Inc. | EOB |
| Sep 13, 2007 | K072387 | KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES KARL STORZ Endoscopy-America, Inc. | EOB |
| Aug 29, 2007 | K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. | EOB |
| Jun 13, 2007 | K070580 | NASOPHARYNGOSCOPE, BRONCHOSCOPE Xion GmbH, DE | EOB |
| May 1, 2007 | K070752 | KSEA MINIATURE ENDOSCOPE, MODEL 11565 KARL STORZ Endoscopy-America, Inc. | EOB |
| Oct 24, 2006 | K063078 | MICROENDOSCOPE Acclarent, Inc. | EOB |
| Sep 6, 2006 | K061663 | ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES Rtc Inc.-Memcath Technologies, LLC | EOB |
| Sep 21, 2005 | K052452 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT Olympus Medical Systems Corporation | EOB |
| Apr 29, 2005 | K050972 | VISION-SCIENCES ENT-3000 SCOPE Vision-Sciences, Inc. | EOB |
| Apr 27, 2004 | K040984 | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE Vision-Sciences, Inc. | EOB |
| Jan 8, 2004 | 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, DE | EOB |
| Oct 16, 2003 | K030857 | MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES Mahe Intl., Inc. | EOB |
| Jul 24, 2003 | K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus Optical Co., Ltd. | EOB |
| Jul 2, 2003 | K031790 | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING Vision-Sciences, Inc. | EOB |
| Apr 1, 2003 | K030572 | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE Henke Sass Wolf of America, Inc. | EOB |
| Jan 28, 2003 | K023004 | LFRE INDIRECT LARYNGOSCOPE Astralite Corp. | EOB |
| Jan 9, 2003 | K024095 | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOB |
| Jul 15, 2002 | K012543 | VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOB |
| May 1, 2002 | K021073 | VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus America, Inc. | EOB |
| Mar 13, 2002 | K020599 | MTP CLEARVISION DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH | EOB |
| Jan 16, 2002 | K013838 | KSEA CLEARVISION LENS IRRIGATION SYSTEM KARL STORZ Endoscopy-America, Inc. | EOB |
| Dec 26, 2001 | K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. | EOB |
| Jul 25, 2001 | K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. | EOB |
| Apr 9, 2001 | K003830 | ENT ENDOSCOPES Global Endoscopy, Inc. | EOB |
| Nov 21, 2000 | K002214 | SINUSCOPE AND BACCESSORIES Pollux Endoscopy, Inc. | EOB |
| Oct 18, 2000 | K002700 | KSEA UNIMAT 12 KARL STORZ Endoscopy-America, Inc. | EOB |
| Sep 24, 1999 | K992526 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE Richard Wolf Medical Instruments Corp. | EOB |
| Jul 13, 1999 | K991560 | NASO-LARYNGO-PHARYNGOSCOPE Fiber Imaging Technologies, Inc. | EOB |
| Mar 31, 1999 | K990354 | ENDOSHEATH Vision-Sciences, Inc. | EOB |
| Feb 2, 1999 | K990213 | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET Gyrus Ent LLC | EOB |
| Jan 29, 1999 | K984369 | DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. | EOB |
| Sep 25, 1998 | K983123 | POC ENT ENDOSCOPE - SINUSCOPE Precision Optics Corp. | EOB |
| Aug 27, 1998 | K982594 | ENDO-SCRUB/ENDO-SCRUB 2 Xomed, Inc. | EOB |
| Aug 13, 1998 | K981751 | SINUSCOPE AND ACCESSORIES Henke Sass Wolf of America, Inc. | EOB |
| May 20, 1998 | K981458 | KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 Karl Storz Endoscopy | EOB |
| Nov 21, 1997 | K972450 | FLEXTIP GRASPER Endius, Inc. | EOB |
| Oct 31, 1997 | K971375 | GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE Wilson Greatbatch Technologies, Inc. | EOB |
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