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 Ambu A/S.

161
Total
161
Cleared
137d
Avg days
1987
Since
161 devices
49–72 of 161
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 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
Cleared Jan 25, 1995
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
K945788
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared Jan 18, 1995
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES
K945381
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 22, 1994
KARL STORZ INSULATED SCISSORS
K944298
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 22, 1994
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K944797
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Oct 14, 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d