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 Ambu A/S, Intuitive Surgical, Inc. and Olympus Medical Systems Corp..

237
Total
237
Cleared
123d
Avg days
1976
Since
237 devices
49–72 of 237
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299
Intuitive Surgical, Inc.
Ear, Nose, Throat · 134d
Cleared Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928
Pentax of America, Inc.
Ear, Nose, Throat · 206d
Cleared Sep 22, 2021
Single Use Guide Sheath Kit-401, K-402
K212667
Olympus Medical Systems Corp.
Anesthesiology · 30d
Cleared Aug 26, 2021
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
K212048
Intuitive Surgical, Inc.
Ear, Nose, Throat · 57d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
K211030
Boston Scientific Corporation
Ear, Nose, Throat · 125d
Cleared Jun 17, 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
K210883
Ambu A/S
Ear, Nose, Throat · 84d
Cleared Jan 26, 2021
Airway Mobilescope
K201300
Olympus Medical Systems Corp.
Ear, Nose, Throat · 256d
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