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
Cleared
Apr 30, 2018
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
Olympus Medical Systems Corp.
Ear, Nose, Throat
231d
Cleared
Apr 26, 2018
LungVision Tool
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
Ambu A/S
Ear, Nose, Throat
113d
Cleared
Mar 22, 2018
Monarch Endoscopy Platform (Monarch Platform)
Auris Surgical Robotics, Inc.
Ear, Nose, Throat
101d
Cleared
Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
Wilson-Cook Medical, Inc.
Ear, Nose, Throat
447d
Cleared
Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
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
Pentax of America, Inc.
Ear, Nose, Throat
63d
Cleared
Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Covidien, LLC
Ear, Nose, Throat
126d
Cleared
Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
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
Ambu A/S
Ear, Nose, Throat
77d
Cleared
Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation
Ear, Nose, Throat
176d
Cleared
Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
Pentax of America, Inc.
Ear, Nose, Throat
304d
Cleared
Jun 17, 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
Covidien
Ear, Nose, Throat
251d
Cleared
Apr 29, 2015
GenCut Core Biopsy System
Covidien, LLC
Ear, Nose, Throat
211d
Cleared
Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
Ambu A/S
Ear, Nose, Throat
220d
Cleared
Jan 10, 2013
EVIS EXERA III VIDEO SYSTEM
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
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat
115d
Cleared
Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
Fujifilm Medical System U.S.A., Inc.
Radiology
60d
Cleared
Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
Olympus Medical Systems Corporation
Ear, Nose, Throat
49d
Cleared
Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
80d
Cleared
Aug 31, 2006
EVIS EXERA 180 SYSTEM
Olympus Medical Systems Corporation
Ear, Nose, Throat
113d
Cleared
Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
Olympus Medical Systems Corporation
Ear, Nose, Throat
143d
Cleared
Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
Olympus Medical Systems Corporation
Ear, Nose, Throat
10d
Cleared
Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
Boston Scientific Corp
Ear, Nose, Throat
14d