EOB · Class II · 21 CFR 874.4760

FDA Product Code EOB: Nasopharyngoscope (flexible Or Rigid)

Visualization of the nasopharynx is essential in the evaluation of nasal, sinus, and upper airway conditions. FDA product code EOB covers flexible and rigid nasopharyngoscopes and their accessories.

These endoscopes allow ENT specialists to directly inspect the nasal cavity, nasopharynx, and hypopharynx for the diagnosis of nasal polyps, sinusitis, tumors, and voice disorders, and to guide procedures including biopsy and intubation.

EOB devices are Class II medical devices, regulated under 21 CFR 874.4760 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Vision-Sciences, Inc. and Olympus Medical Systems Corp..

162
Total
162
Cleared
137d
Avg days
1987
Since
162 devices
49–72 of 162
Cleared Jan 27, 2015
SCHOELLY SINUSCOPE
K142249
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 166d
Cleared Jun 09, 2014
ECLERIS SINUSCOPE
K131323
Ecleris USA
Ear, Nose, Throat · 397d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Apr 09, 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K132009
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 282d
Cleared Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 582d
Cleared May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097
Acclarent, Inc.
Ear, Nose, Throat · 134d
Cleared May 18, 2011
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
K102733
Vision-Sciences, Inc.
Ear, Nose, Throat · 238d
Cleared Feb 15, 2011
FINESS ENDOSCOPE
K102366
Entellus Medical, Inc.
Ear, Nose, Throat · 179d
Cleared Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577
Acclarent, Inc.
Ear, Nose, Throat · 311d
Cleared Feb 25, 2010
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125
Vision-Sciences, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 31, 2008
CLEARVIEW ENDOSCOPE COVER
K080740
Invotec International, Inc.
Ear, Nose, Throat · 289d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569
Entellus Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 20d
Cleared Aug 29, 2007
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
K072073
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared May 01, 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 43d
Cleared Oct 24, 2006
MICROENDOSCOPE
K063078
Acclarent, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452
Olympus Medical Systems Corporation
Ear, Nose, Throat · 15d
Cleared Apr 29, 2005
VISION-SCIENCES ENT-3000 SCOPE
K050972
Vision-Sciences, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984
Vision-Sciences, Inc.
Ear, Nose, Throat · 12d
Cleared Jul 24, 2003
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K031648
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Jul 02, 2003
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
K031790
Vision-Sciences, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 09, 2003
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K024095
Vision-Sciences, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
K012543
Vision-Sciences, Inc.
Ear, Nose, Throat · 342d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073
Olympus America, Inc.
Ear, Nose, Throat · 29d