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 Acclarent, Inc..

162
Total
162
Cleared
137d
Avg days
1987
Since
162 devices
49–72 of 162
Cleared Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452
Olympus Medical Systems Corporation
Ear, Nose, Throat · 15d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
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 Jan 29, 1999
DCI ENDOSCOPE
K984369
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 27, 1998
ENDO-SCRUB/ENDO-SCRUB 2
K982594
Xomed, Inc.
Ear, Nose, Throat · 34d
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 Sep 08, 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 38d
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 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 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 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 Apr 07, 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 22d
Cleared Apr 06, 1995
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K951201
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Feb 27, 1995
KARL STORZ TELE-SCRUB
K950334
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 27, 1995
KARL STORZ VISCOUS FLUID INJECTION SET
K950603
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 18d
Cleared Feb 24, 1995
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K950338
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 21, 1995
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE
K944861
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d
Cleared Feb 09, 1995
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K946148
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d