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
97–120 of 163
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
Cleared Aug 27, 1996
KSEA UNIMAT PLUS
K962898
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 33d
Cleared Aug 05, 1996
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
K950809
Vision-Sciences, Inc.
Ear, Nose, Throat · 530d
Cleared Jul 02, 1996
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K961591
Vision-Sciences, Inc.
Ear, Nose, Throat · 69d
Cleared May 08, 1996
FIVE STAR BRONCHOSCOPE
K960876
Five Star Medical, Inc.
Ear, Nose, Throat · 65d
Cleared Dec 22, 1995
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
K942265
Vision-Sciences, Inc.
Ear, Nose, Throat · 592d
Cleared Dec 22, 1995
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
K955560
Trebay Medical Corp.
Ear, Nose, Throat · 16d
Cleared Nov 22, 1995
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K953771
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 100d
Cleared Nov 15, 1995
GLANZ CARCINOMA GAUGE, KSEA
K954348
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Nov 13, 1995
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
K954336
Aust & Taylor Medical Corp.
Ear, Nose, Throat · 56d
Cleared Oct 07, 1995
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE
K953888
Vista Medical Technologies, Inc.
Ear, Nose, Throat · 51d
Cleared May 24, 1995
SINUSCOPE
K940317
Stephen Chakoff, Inc.
Ear, Nose, Throat · 485d