EOQ · Class II · 21 CFR 874.4680

FDA Product Code EOQ: Bronchoscope (flexible Or Rigid)

FDA product code EOQ covers flexible and rigid bronchoscopes and their accessories.

These endoscopic instruments allow clinicians to directly visualize the airways — from the larynx to the segmental bronchi — for diagnostic and therapeutic purposes. They are used in the evaluation of lung lesions, foreign body removal, airway management, and bronchial lavage.

EOQ devices are Class II medical devices, regulated under 21 CFR 874.4680 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.

244
Total
244
Cleared
125d
Avg days
1976
Since
244 devices
217–240 of 244
Cleared Jun 28, 1991
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412
Olympus Corp.
Ear, Nose, Throat · 88d
Cleared Apr 29, 1991
BRONCHOSCOPE BF-N20
K910423
Olympus Corp.
Ear, Nose, Throat · 89d
Cleared Mar 27, 1990
PORT-O-SCOPE(TM)
K895948
North American Medical Products, Inc.
Ear, Nose, Throat · 168d
Cleared Mar 09, 1990
BIOPSY FORCEPS, (NON-RIGID)
K896146
Portlyn Corp.
Ear, Nose, Throat · 137d
Cleared Mar 05, 1990
EXMOOR BITE BUFFER
K893006
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 315d
Cleared Oct 31, 1989
BIOPSY FORCEPS
K895415
Symbiosis Corp.
Ear, Nose, Throat · 56d
Cleared Jun 21, 1989
CANNULATED BIOPSY FORCEPS
K892687
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 69d
Cleared Mar 09, 1987
CO2 LASER BRONCHOSCOPE SET
K870063
Tti Medical
Ear, Nose, Throat · 61d
Cleared Feb 05, 1987
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K862835
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 195d
Cleared Mar 12, 1986
DUMON/HARRELL
K854414
Bryan Corp.
Ear, Nose, Throat · 128d
Cleared Feb 28, 1986
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K854581
Machida America, Inc.
Ear, Nose, Throat · 105d
Cleared Jun 11, 1985
MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
K844834
Machida America, Inc.
Ear, Nose, Throat · 181d
Cleared Feb 10, 1984
ENDOSCOPIC COUPLER
K833483
Merrimack Laboratories
Ear, Nose, Throat · 126d
Cleared Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
K832449
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 57d
Cleared Sep 20, 1983
BRONCHO FIBERSCOPE FB-19C
K832492
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 55d
Cleared Aug 01, 1983
BRONCHO-FIBERSCOPE
K832010
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 26, 1983
LASER BRONCHOSCOPE
K831240
Eder Instrument Co, Inc.
Ear, Nose, Throat · 102d
Cleared Oct 26, 1982
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K822257
Kelleher Corp.
Ear, Nose, Throat · 89d
Cleared Oct 26, 1982
PENTAX BRONCHOFIBERSCOPE #FB-19E
K822844
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 33d
Cleared Aug 20, 1982
RIGID FIBEROPTIC ENDOSCOPES
K822180
Kelleher Corp.
Ear, Nose, Throat · 28d
Cleared Aug 16, 1982
LASER BRONCHOSCOPE
K822136
Laser Industries of Tel Aviv
Ear, Nose, Throat · 27d
Cleared Jul 01, 1981
ACMI ASPIRATOR KIT #8808
K811218
American Cystocope Makers, Inc.
Ear, Nose, Throat · 58d
Cleared May 27, 1981
PENTAX BRONCHOFIBERSCOPE #FB-15A
K811059
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 40d
Cleared May 13, 1981
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K811181
American Optical Corp.
Ear, Nose, Throat · 15d