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
73–96 of 162
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 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
Cleared Aug 13, 1998
SINUSCOPE AND ACCESSORIES
K981751
Henke Sass Wolf of America, Inc.
Ear, Nose, Throat · 87d
Cleared May 20, 1998
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
K981458
Karl Storz Endoscopy
Ear, Nose, Throat · 27d
Cleared Nov 21, 1997
FLEXTIP GRASPER
K972450
Endius, Inc.
Ear, Nose, Throat · 144d
Cleared Oct 31, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K971375
Wilson Greatbatch Technologies, Inc.
Ear, Nose, Throat · 200d
Cleared Sep 08, 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 38d
Cleared Jun 26, 1997
MEDIVISION SINOSCOPE
K971995
Medivision Scope Service Center, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 04, 1997
SHARPSITE AC
K965233
Xomed, Inc.
Ear, Nose, Throat · 94d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d
Cleared Nov 27, 1996
GALILEO ENDOSCOPES
K962116
Galileo Electro-Optics Corp.
Ear, Nose, Throat · 180d
Cleared Nov 26, 1996
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 69d
Cleared Nov 07, 1996
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 69d
Cleared Sep 11, 1996
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
K962255
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 27, 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 67d