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..

32
Total
32
Cleared
139d
Avg days
2021
Since

List of Bronchoscope (flexible Or Rigid) devices cleared through 510(k)

32 devices
1–24 of 32
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 05, 2025
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731
Karl Storz SE & CO. KG
Ear, Nose, Throat · 182d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862
Olympus Medical Systems Corp.
Ear, Nose, Throat · 94d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 04, 2025
Disposable Balloon Catheter B5-2C
K250118
Olympus Medical Systems Corporation
Anesthesiology · 139d
Cleared May 30, 2025
Disposable Biopsy Forceps (FB-211D)
K250957
Olympus Medical Systems Corporation
Anesthesiology · 60d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070
Intuitive Surgical, Inc.
Ear, Nose, Throat · 70d
Cleared Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K240135
Intuitive Surgical, Inc.
Ear, Nose, Throat · 76d
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K232860
Pentax of America, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
K231970
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671
Ambu A/S
Ear, Nose, Throat · 50d
Cleared Dec 18, 2023
Ion Endoluminal System (IF1000)
K232984
Intuitive Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582
Ambu A/S
Ear, Nose, Throat · 26d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Jun 15, 2023
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
K222861
Olympus Medical Systems Corporation
Ear, Nose, Throat · 266d
Cleared Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
K223299
Ambu A/S
Ear, Nose, Throat · 217d
Cleared Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
K221340
Boston Scientific Corporation
Anesthesiology · 297d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
K223782
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235
Pentax of America, Inc.
Ear, Nose, Throat · 447d
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 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

How to use this database

This page lists all FDA 510(k) submissions for Bronchoscope (flexible Or Rigid) devices (product code EOQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →