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 Olympus Medical Systems Corp., KARL STORZ Endoscopy-America, Inc. and Ambu A/S.

244
Total
244
Cleared
125d
Avg days
1976
Since
244 devices
145–168 of 244
Cleared Oct 16, 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K033225
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 10d
Cleared Mar 28, 2003
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
K022446
Aomori Olympus Co., Ltd.
Ear, Nose, Throat · 246d
Cleared Jan 31, 2003
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
K023984
The Olympus Optical Co.
Ear, Nose, Throat · 60d
Cleared Jan 10, 2003
DUAL-LUMEN CATHETER
K024165
Bistech, Inc.
Ear, Nose, Throat · 24d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K022546
Horizons Intl. Corp.
Ear, Nose, Throat · 11d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d
Cleared Nov 27, 2001
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
K013731
Gimmi GmbH
Ear, Nose, Throat · 18d
Cleared Oct 01, 2001
EXHALE PROBE
K013111
Broncus Technologies, Inc.
Radiology · 13d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared May 08, 2001
EXHALE RF PROBE
K011267
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d
Cleared Jan 28, 2000
COAGULATION ELECTRODE, MODEL 2000
K993900
Broncus Technologies, Inc.
Ear, Nose, Throat · 73d
Cleared Apr 27, 1999
PILLING WECK SURGICAL Y STENT FORCEPS
K990547
Pilling Weck, Inc.
Ear, Nose, Throat · 64d
Cleared Jan 29, 1999
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
K983878
E. Benson Hood Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 08, 1998
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K984157
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 19d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
K983122
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
K983124
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Sep 29, 1998
LSVP INTERNATIONAL BIOPSY FORCEPS
K982983
Lsvp Intl., Inc.
Ear, Nose, Throat · 34d
Cleared Jun 08, 1998
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
K981543
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared May 01, 1998
BRONCHIAL CATHETER SYSTEM
K980046
Broncus Technologies, Inc.
Ear, Nose, Throat · 115d
Cleared Mar 13, 1998
COMBICATH CATHETER
K974642
Plastimed Laboratoire Pharmaceutique
Ear, Nose, Throat · 88d
Cleared Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K970107
Urohealth Systems, Inc.
Ear, Nose, Throat · 309d
Cleared Dec 23, 1996
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
K963795
Vision-Sciences, Inc.
Ear, Nose, Throat · 91d
Cleared Sep 20, 1996
TBAN
K963252
Boston Scientific Corp
Ear, Nose, Throat · 32d