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
97–120 of 238
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 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 Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315
Boston Scientific Corporation
Ear, Nose, Throat · 176d
Cleared Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 80d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Sep 20, 1996
TBAN
K963252
Boston Scientific Corp
Ear, Nose, Throat · 32d
Cleared May 14, 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 11, 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 13d
Cleared Jan 17, 1996
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
K954797
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 91d
Cleared Oct 06, 1995
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K954125
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 26, 1995
DISTENDING DIVERTICULOSCOPE
K953596
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 56d
Cleared Jul 03, 1995
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
K952081
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared May 15, 1995
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
K951826
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Mar 31, 1995
KARL STORZ STENT APPLICATOR FORCEPS
K950965
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 29d
Cleared Jan 24, 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 673d
Cleared Aug 23, 1994
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 01, 1983
BRONCHO-FIBERSCOPE
K832010
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 39d