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
97–120 of 241
Cleared Apr 30, 2018
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
K172726
Olympus Medical Systems Corp.
Ear, Nose, Throat · 231d
Cleared Apr 26, 2018
LungVision Tool
K172955
Bodyvision Medical , Ltd.
Ear, Nose, Throat · 212d
Cleared Mar 28, 2018
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727
Ambu A/S
Ear, Nose, Throat · 113d
Cleared Mar 22, 2018
Monarch Endoscopy Platform (Monarch Platform)
K173760
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 101d
Cleared Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 447d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291
Fujifilm Medical Systems U.S.A, Inc.
Ear, Nose, Throat · 262d
Cleared Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
K173554
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537
Covidien, LLC
Ear, Nose, Throat · 126d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248
Boston Scientific Corporation
Ear, Nose, Throat · 129d
Cleared Sep 01, 2016
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
K161656
Ambu A/S
Ear, Nose, Throat · 77d
Cleared Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315
Boston Scientific Corporation
Ear, Nose, Throat · 176d
Cleared Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
K143727
Pentax of America, Inc.
Ear, Nose, Throat · 304d
Cleared Jun 17, 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
K142934
Covidien
Ear, Nose, Throat · 251d
Cleared Apr 29, 2015
GenCut Core Biopsy System
K142839
Covidien, LLC
Ear, Nose, Throat · 211d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845
Ambu A/S
Ear, Nose, Throat · 220d
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 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 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