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
Cleared
Sep 06, 2019
Precision S 4K Sinuscope
Stryker
Ear, Nose, Throat
134d
Cleared
Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
Ambu A/S
Ear, Nose, Throat
88d
Cleared
Jun 12, 2019
PENTAX Medical ENT Video Imaging System
Pentax of America, Inc.
Ear, Nose, Throat
163d
Cleared
May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
Ambu A/S
Ear, Nose, Throat
28d
Cleared
Mar 22, 2019
CMOS Video-Rhino-Laryngoscope System
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
Olympus Medical Systems Corp.
Ear, Nose, Throat
187d
Cleared
Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
Pentax of America, Inc.
Ear, Nose, Throat
92d
Cleared
Nov 30, 2018
Ambu aScope RLS Slim
Ambu A/S
Ear, Nose, Throat
198d
Cleared
Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
Olympus Medical Systems Corp.
Ear, Nose, Throat
147d
Cleared
Jul 18, 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
Pentax Medical
Ear, Nose, Throat
470d
Cleared
Apr 20, 2018
Sharpsite AC Rigid Endsocope
Medtronic Xomed, Inc.
Ear, Nose, Throat
121d
Cleared
Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
Pentax Medical
Ear, Nose, Throat
261d
Cleared
Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
266d
Cleared
Apr 20, 2017
PENTAX Medical ENT Video Imaging System
Pentax of America, Inc.
Ear, Nose, Throat
261d
Cleared
Mar 02, 2017
TIPCAM 1S 3D System
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
185d
Cleared
Apr 05, 2016
ULTRA Telescopes
Olympus Winter & Ibe GmbH
Ear, Nose, Throat
174d
Cleared
Jan 15, 2016
InstaClear Lens Cleaner
Gyrus Acmi, Inc.
Ear, Nose, Throat
134d
Cleared
Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Acclarent, Inc.
Ear, Nose, Throat
262d
Cleared
Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
582d
Cleared
May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Acclarent, Inc.
Ear, Nose, Throat
134d
Cleared
Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Acclarent, Inc.
Ear, Nose, Throat
311d
Cleared
Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
20d
Cleared
May 01, 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
43d
Cleared
Oct 24, 2006
MICROENDOSCOPE
Acclarent, Inc.
Ear, Nose, Throat
14d