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 Mill-Rose Laboratory.

241
Total
241
Cleared
124d
Avg days
1976
Since
241 devices
121–144 of 241
Cleared Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K131028
Pentax Medical Company
Ear, Nose, Throat · 363d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845
Ambu A/S
Ear, Nose, Throat · 220d
Cleared Oct 15, 2013
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K131234
Broncus Medical, Inc.
Ear, Nose, Throat · 167d
Cleared Jul 02, 2013
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K131401
Mercator Medsystems, Inc.
Ear, Nose, Throat · 48d
Cleared Jan 10, 2013
EVIS EXERA III VIDEO SYSTEM
K121959
Olympus Medical Systems Corp.
Ear, Nose, Throat · 189d
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Aug 03, 2009
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
K091768
Vision-Sciences, Inc.
Ear, Nose, Throat · 48d
Cleared May 22, 2009
DIAGNOSTIC CATHETER SYSTEM
K091250
Cardinal Health, Inc.
Ear, Nose, Throat · 24d
Cleared Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720
Olympus Medical Systems Corporation
Ear, Nose, Throat · 49d
Cleared Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 31, 2006
EVIS EXERA 180 SYSTEM
K061313
Olympus Medical Systems Corporation
Ear, Nose, Throat · 113d
Cleared Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243
Olympus Medical Systems Corporation
Ear, Nose, Throat · 143d
Cleared May 19, 2005
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K050907
Fujinon, Inc.
Ear, Nose, Throat · 38d
Cleared Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220
Olympus Medical Systems Corporation
Ear, Nose, Throat · 10d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966
Cook, Inc.
Ear, Nose, Throat · 112d
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 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 Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073
The Olympus Optical Co.
Ear, Nose, Throat · 39d
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