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..

163
Total
163
Cleared
137d
Avg days
1987
Since
163 devices
73–96 of 163
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984
Vision-Sciences, Inc.
Ear, Nose, Throat · 12d
Cleared Jan 08, 2004
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
K032822
Asap Endoscopic Products GmbH
Ear, Nose, Throat · 120d
Cleared Oct 16, 2003
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
K030857
Mahe Intl., Inc.
Ear, Nose, Throat · 212d
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 Apr 01, 2003
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
K030572
Henke Sass Wolf of America, Inc.
Ear, Nose, Throat · 36d
Cleared Jan 28, 2003
LFRE INDIRECT LARYNGOSCOPE
K023004
Astralite Corp.
Ear, Nose, Throat · 141d
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
Cleared Mar 13, 2002
MTP CLEARVISION DISPOSABLE TUBING SET
K020599
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 19d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Jul 25, 2001
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K011869
The Olympus Optical Co.
Ear, Nose, Throat · 41d
Cleared Apr 09, 2001
ENT ENDOSCOPES
K003830
Global Endoscopy, Inc.
Ear, Nose, Throat · 119d
Cleared Nov 21, 2000
SINUSCOPE AND BACCESSORIES
K002214
Pollux Endoscopy, Inc.
Ear, Nose, Throat · 120d
Cleared Oct 18, 2000
KSEA UNIMAT 12
K002700
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 24, 1999
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 58d
Cleared Jul 13, 1999
NASO-LARYNGO-PHARYNGOSCOPE
K991560
Fiber Imaging Technologies, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 31, 1999
ENDOSHEATH
K990354
Vision-Sciences, Inc.
Ear, Nose, Throat · 54d
Cleared Feb 02, 1999
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
K990213
Gyrus Ent LLC
Ear, Nose, Throat · 11d
Cleared Jan 29, 1999
DCI ENDOSCOPE
K984369
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 25, 1998
POC ENT ENDOSCOPE - SINUSCOPE
K983123
Precision Optics Corp.
Ear, Nose, Throat · 86d
Cleared Aug 27, 1998
ENDO-SCRUB/ENDO-SCRUB 2
K982594
Xomed, Inc.
Ear, Nose, Throat · 34d