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
Feb 14, 2019
Ion Endoluminal System
Intuitive Surgical
Ear, Nose, Throat
185d
Cleared
Jan 04, 2019
GlideScope BFlex Single-Use Bronchoscope System
Verathon Medical (Canada) Ulc
Ear, Nose, Throat
44d
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
Nov 20, 2017
B7 2C Occlusion Balloon
Spiration, Inc.
Ear, Nose, Throat
182d
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
Feb 09, 2017
PeriFLEX
Spiration, Inc.
Ear, Nose, Throat
143d
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
May 26, 2016
Auris Robotic Endoscopy System (ARES)
Auris Surgical Robotics, Inc.
Ear, Nose, Throat
283d
Cleared
May 19, 2016
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
Prosurg, Inc.
Ear, Nose, Throat
262d
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
Jun 11, 2015
PulmoVia Working Channel
Sanovas, Inc.
Ear, Nose, Throat
126d
Cleared
Apr 29, 2015
GenCut Core Biopsy System
Covidien, LLC
Ear, Nose, Throat
211d
Cleared
Apr 24, 2015
Flexible 19G EBUS Needle
Spiration, Inc.
Ear, Nose, Throat
200d
Cleared
Dec 17, 2014
VIDEO BRONCHOSCOPE SYSTEM
Scholly Fiberoptic GmbH
Ear, Nose, Throat
208d
Cleared
Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
Pentax Medical Company
Ear, Nose, Throat
302d