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
193–216 of 244
Cleared Feb 27, 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636
Olympus America, Inc.
Ear, Nose, Throat · 14d
Cleared Jan 24, 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 673d
Cleared Dec 21, 1994
BRONCHOSCOPE,NON-RIGID
K944976
Citation Medical Corp.
Ear, Nose, Throat · 71d
Cleared Nov 30, 1994
MILL-ROSE HARRELL BRONCHIAL BRUSH
K944649
Mill-Rose Laboratory
Ear, Nose, Throat · 70d
Cleared Nov 22, 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650
Mill-Rose Laboratory
Ear, Nose, Throat · 62d
Cleared Aug 23, 1994
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 17, 1994
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
K942388
Technology Marketing Group
Ear, Nose, Throat · 90d
Cleared Jul 18, 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 124d
Cleared May 04, 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521
Mill-Rose Laboratory
Ear, Nose, Throat · 89d
Cleared May 04, 1994
FLEXIBLE GRASPING FORCEPS
K941161
Surgical Technologies, Inc.
Ear, Nose, Throat · 54d
Cleared Apr 28, 1994
FLEXIBLE BIOPSY CUP FORCEPS
K941158
Surgical Technologies, Inc.
Ear, Nose, Throat · 48d
Cleared Jan 26, 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 103d
Cleared Nov 01, 1993
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K933433
Fujinon, Inc.
Ear, Nose, Throat · 110d
Cleared Oct 07, 1993
EVIS 200 SYSTEM
K931154
Olympus Corp.
Ear, Nose, Throat · 213d
Cleared Jul 13, 1993
MILL-ROSE PULMONARY FORCEPS
K922204
Mill-Rose Laboratory
Ear, Nose, Throat · 428d
Cleared Mar 26, 1993
CANNULATED BIOPSY FORCEPS
K926430
Thomasville Medical Assoc.
Ear, Nose, Throat · 93d
Cleared Nov 18, 1992
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Sep 14, 1992
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922937
Optimed Technologies, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 20, 1992
IMAGICA MICRO-ENDOSCOPE
K921393
Fiberoptic Medical Products, Inc.
Ear, Nose, Throat · 150d
Cleared Mar 27, 1992
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
K915816
Gi Supply
Ear, Nose, Throat · 88d
Cleared Mar 24, 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025
Olympus Corp.
Ear, Nose, Throat · 81d
Cleared Dec 10, 1991
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181
Mill-Rose Laboratory
Ear, Nose, Throat · 83d
Cleared Sep 24, 1991
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K910536
Mill-Rose Laboratory
Ear, Nose, Throat · 228d
Cleared Jul 29, 1991
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
K911922
Delta Industries, Inc.
Ear, Nose, Throat · 90d