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
49–72 of 238
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Sep 26, 2022
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
K221631
Olympus Medical Systems Corp.
Ear, Nose, Throat · 112d
Cleared Aug 15, 2022
Recon Steerable Sheath
K221302
Serpex Medical, Inc.
Ear, Nose, Throat · 102d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014
Boston Scientific Corporation
Ear, Nose, Throat · 20d
Cleared Jul 25, 2022
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K220606
Ambu A/S
Ear, Nose, Throat · 145d
Cleared Jul 08, 2022
Single-Use Video Bronchoscopes, Digital Controller
K213782
Micro-Tech (Nanjing) Co., Lts
Ear, Nose, Throat · 217d
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299
Intuitive Surgical, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 16, 2022
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
K220399
OTU Medical, Inc.
Ear, Nose, Throat · 125d
Cleared Feb 28, 2022
Vathin Video Bronchoscope System
K213635
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 103d
Cleared Feb 16, 2022
Broncoflex Agile, Broncoflex Vortex, Screeni
K212886
Axess Vision Technology
Ear, Nose, Throat · 159d
Cleared Dec 29, 2021
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
K212656
Karl Storz Endoscopy America
Ear, Nose, Throat · 128d
Cleared Nov 24, 2021
Bronchoscope System
K211169
Shanghai AnQing Medical Instrument Co., Ltd.
Ear, Nose, Throat · 219d
Cleared Nov 03, 2021
GlideScope BFlex 2.8 Single-Use Bronchoscope
K211947
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 133d
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 Jul 28, 2021
Broncho Videoscope System
K210379
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 169d
Cleared Jul 09, 2021
Monarch Platform
K211493
Auris Health, Inc.
Ear, Nose, Throat · 57d
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 Apr 29, 2021
Rescue Pulmonary Grasping Forceps
K202987
Anrei Medical (Hangzhou) Co., Ltd.
Anesthesiology · 211d
Cleared Feb 19, 2021
SPiN Vision Video Bronchoscope System
K202346
Veran Medical Technologies, Inc.
Ear, Nose, Throat · 185d
Cleared Jan 26, 2021
Airway Mobilescope
K201300
Olympus Medical Systems Corp.
Ear, Nose, Throat · 256d