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 Pentax of America, Inc..

162
Total
162
Cleared
137d
Avg days
1987
Since
162 devices
73–96 of 162
Cleared Feb 07, 1995
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944671
Jedmed Instrument Co.
Ear, Nose, Throat · 138d
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 Jan 11, 1995
OLYMPUS NASAL AND SINUS ENDOSCOPES
K944072
Olympus America, Inc.
Ear, Nose, Throat · 142d
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 Nov 07, 1994
SINUSCOPE
K944186
Stryker Endoscopy
Ear, Nose, Throat · 73d
Cleared Oct 14, 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 11, 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665
Olympus America, Inc.
Ear, Nose, Throat · 75d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 26, 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 38d
Cleared May 17, 1993
NASAL/PARANASAL ENDOSCOPE
K930931
Storz Instrument Co.
Ear, Nose, Throat · 83d
Cleared Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 82d
Cleared Jan 26, 1990
FLEXIBLE NASOPHARYNGOSCOPE
K896297
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 04, 1988
ENDOSCOPES FOR SINUS SURGERY
K874215
Richards Medical Co., Inc.
Ear, Nose, Throat · 80d