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
121–144 of 163
Cleared Apr 10, 1995
CITATION SINUSCOPE
K951249
Citation Medical Corp.
Ear, Nose, Throat · 21d
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 Mar 24, 1995
ENDOSCOPE SHEATH
K940028
Xomed-Treace, Inc.
Ear, Nose, Throat · 445d
Cleared Mar 06, 1995
TRANSTYMPANIC ENDOSCOPE
K945081
Endooptiks, Inc.
Ear, Nose, Throat · 140d
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 17, 1995
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
K946011
Argus Medical Co., Inc.
Ear, Nose, Throat · 70d
Cleared Feb 09, 1995
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K946148
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 07, 1995
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944671
Jedmed Instrument Co.
Ear, Nose, Throat · 138d
Cleared Feb 02, 1995
JARIT RECOMMENDED SINUS INSTRUMENTS
K944670
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 133d
Cleared Jan 26, 1995
OPTUS SINUSCOPES AND ACCESSORIES
K944656
Optus, Inc.
Ear, Nose, Throat · 127d
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 24, 1994
TROCARS,CANNULAE, SHEATHS
K943816
Karl Storz Endoskop GmbH
Ear, Nose, Throat · 19d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d