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 Feb 14, 2019
Ion Endoluminal System
K182188
Intuitive Surgical
Ear, Nose, Throat · 185d
Cleared Jan 04, 2019
GlideScope BFlex Single-Use Bronchoscope System
K183256
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
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 Nov 20, 2017
B7 2C Occlusion Balloon
K171492
Spiration, Inc.
Ear, Nose, Throat · 182d
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 Feb 09, 2017
PeriFLEX
K162611
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
K161656
Ambu A/S
Ear, Nose, Throat · 77d
Cleared May 26, 2016
Auris Robotic Endoscopy System (ARES)
K152319
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 283d
Cleared May 19, 2016
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
K152466
Prosurg, Inc.
Ear, Nose, Throat · 262d
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 Jun 11, 2015
PulmoVia Working Channel
K150280
Sanovas, Inc.
Ear, Nose, Throat · 126d
Cleared Apr 29, 2015
GenCut Core Biopsy System
K142839
Covidien, LLC
Ear, Nose, Throat · 211d
Cleared Apr 24, 2015
Flexible 19G EBUS Needle
K142909
Spiration, Inc.
Ear, Nose, Throat · 200d
Cleared Dec 17, 2014
VIDEO BRONCHOSCOPE SYSTEM
K141366
Scholly Fiberoptic GmbH
Ear, Nose, Throat · 208d
Cleared Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K131946
Pentax Medical Company
Ear, Nose, Throat · 302d