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., Olympus Medical Systems Corp. and Pentax of America, Inc..

162
Total
162
Cleared
137d
Avg days
1987
Since
162 devices
25–48 of 162
Cleared Sep 06, 2019
Precision S 4K Sinuscope
K191102
Stryker
Ear, Nose, Throat · 134d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972
Ambu A/S
Ear, Nose, Throat · 88d
Cleared Jun 12, 2019
PENTAX Medical ENT Video Imaging System
K183691
Pentax of America, Inc.
Ear, Nose, Throat · 163d
Cleared May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080
Ambu A/S
Ear, Nose, Throat · 28d
Cleared Mar 22, 2019
CMOS Video-Rhino-Laryngoscope System
K182186
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 221d
Cleared Feb 06, 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
K182102
Olympus Medical Systems Corp.
Ear, Nose, Throat · 187d
Cleared Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846
Pentax of America, Inc.
Ear, Nose, Throat · 92d
Cleared Nov 30, 2018
Ambu aScope RLS Slim
K181286
Ambu A/S
Ear, Nose, Throat · 198d
Cleared Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240
Olympus Medical Systems Corp.
Ear, Nose, Throat · 147d
Cleared Jul 18, 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011
Pentax Medical
Ear, Nose, Throat · 470d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855
Medtronic Xomed, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156
Pentax Medical
Ear, Nose, Throat · 261d
Cleared Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 266d
Cleared Apr 20, 2017
PENTAX Medical ENT Video Imaging System
K162151
Pentax of America, Inc.
Ear, Nose, Throat · 261d
Cleared Mar 02, 2017
TIPCAM 1S 3D System
K162410
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 185d
Cleared Apr 05, 2016
ULTRA Telescopes
K153009
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 174d
Cleared Jan 15, 2016
InstaClear Lens Cleaner
K152531
Gyrus Acmi, Inc.
Ear, Nose, Throat · 134d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433
Acclarent, Inc.
Ear, Nose, Throat · 262d
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 Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577
Acclarent, Inc.
Ear, Nose, Throat · 311d
Cleared Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 20d
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