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
145–163 of 163
Cleared Jul 18, 1994
XOMED-TREACE SCOPESHEATH
K933672
Xomed-Treace, Inc.
Ear, Nose, Throat · 355d
Cleared May 16, 1994
JARIT RECOMMENDED SINUS INSTRUMENTS
K941565
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 24, 1994
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
K936257
Mitsubishi Cable America, Inc.
Ear, Nose, Throat · 84d
Cleared Jan 27, 1994
NASOPHARYNGOSCOPE
K934422
Marks & Murase
Ear, Nose, Throat · 136d
Cleared Jan 05, 1994
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
K933105
Xomed-Treace, Inc.
Ear, Nose, Throat · 194d
Cleared Nov 22, 1993
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K933247
Vision-Sciences, Inc.
Ear, Nose, Throat · 143d
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 Jan 15, 1993
ENDOSHEATH
K925421
Vision-Sciences, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 06, 1992
DISPOSABLE PROTECTIVE SHEATH
K921244
Vision-Sciences, Inc.
Ear, Nose, Throat · 204d
Cleared Sep 04, 1992
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
K920439
Omega Universal Technologies, Ltd.
Ear, Nose, Throat · 214d
Cleared Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 82d
Cleared Oct 31, 1990
SCOPESCRUBBER(TM)
K902683
Healthtek Microsurgical, Inc.
Ear, Nose, Throat · 134d
Cleared Apr 10, 1990
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
K900176
Machida, Inc.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
FLEXIBLE NASOPHARYNGOSCOPE
K896297
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Nov 17, 1989
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
K895245
Optimed Technologies, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 10, 1988
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
K882744
Effner, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 04, 1988
ENDOSCOPES FOR SINUS SURGERY
K874215
Richards Medical Co., Inc.
Ear, Nose, Throat · 80d
Cleared Feb 10, 1987
AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
K864821
Reichert-Jung, Inc.
Ear, Nose, Throat · 63d