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 Intuitive Surgical, Inc..

238
Total
238
Cleared
123d
Avg days
1976
Since
238 devices
73–96 of 238
Cleared Jan 21, 2021
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
K201758
Olympus Medical Systems Corp.
Ear, Nose, Throat · 206d
Cleared Jan 14, 2021
EasyPath RF Introducer Sheath
K200702
Broncus Medical, Inc.
Ear, Nose, Throat · 302d
Cleared Dec 17, 2020
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
K200342
Olympus Medical Systems Corp.
Ear, Nose, Throat · 310d
Cleared Nov 16, 2020
Ion Endoluminal System
K202370
Intuitive Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Oct 22, 2020
Broncoflex Agile
K202180
Axess Vision Technology
Ear, Nose, Throat · 79d
Cleared Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678
Pentax of America, Inc.
Ear, Nose, Throat · 136d
Cleared Jun 26, 2020
Ion Endoluminal System
K201146
Intuitive Surgical, Inc.
Ear, Nose, Throat · 58d
Cleared Apr 24, 2020
Single Use Biopsy Forceps FB-456D
K200397
Olympus Medical Systems Corp.
Ear, Nose, Throat · 66d
Cleared Apr 15, 2020
Monarch Platform
K193534
Auris Health, Inc.
Ear, Nose, Throat · 117d
Cleared Mar 06, 2020
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
K192164
Olympus Medical Systems Corp.
Anesthesiology · 210d
Cleared Feb 13, 2020
Vathin Video Bronchoscope System
K191828
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 220d
Cleared Jan 16, 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared Nov 26, 2019
Ion Endoluminal System
K192367
Intuitive Surgical, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 06, 2019
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516
Pentax of America, Inc.
Ear, Nose, Throat · 262d
Cleared Sep 05, 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Aug 23, 2019
FUJIFILM Bronchoscope
K183607
Fujifilm Corporation
Ear, Nose, Throat · 240d
Cleared Aug 21, 2019
GlideScope BFlex 5.8 Single-Use Bronchoscope
K191948
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared May 23, 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
K183654
Pentax of America, Inc.
Ear, Nose, Throat · 147d
Cleared Apr 04, 2019
FUJIFILM Video Bronchoscopes
K182253
Fujifilm Corporation
Ear, Nose, Throat · 227d
Cleared Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
K183085
Boston Scientific Corporation
Anesthesiology · 122d
Cleared Feb 22, 2019
FUJIFILM Ultrasonic Endoscope
K182825
Fujifilm Corporation
Ear, Nose, Throat · 141d
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