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 Mill-Rose Laboratory.

241
Total
241
Cleared
124d
Avg days
1976
Since
241 devices
121–144 of 241
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966
Cook, Inc.
Ear, Nose, Throat · 112d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared Dec 08, 1998
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K984157
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 19d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
K983122
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
K983124
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Sep 20, 1996
TBAN
K963252
Boston Scientific Corp
Ear, Nose, Throat · 32d
Cleared Sep 09, 1996
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K963033
Olympus America, Inc.
Ear, Nose, Throat · 35d
Cleared Aug 20, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
K962485
Olympus America, Inc.
Ear, Nose, Throat · 55d
Cleared Aug 20, 1996
OLYMPUS B5-2C/B7-2C BALLOON CATHETER
K962901
Olympus America, Inc.
Ear, Nose, Throat · 26d
Cleared Aug 09, 1996
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
K962380
Olympus America, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 09, 1996
OLYPUS FG SERIES GRASPING FORCEPS
K962533
Olympus America, Inc.
Ear, Nose, Throat · 42d
Cleared Aug 05, 1996
OLYMPUS BASKET GRASPERS
K962367
Olympus America, Inc.
Ear, Nose, Throat · 47d
Cleared Aug 02, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K962378
Olympus America, Inc.
Ear, Nose, Throat · 43d
Cleared Jul 30, 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K962555
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 29, 1996
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
K962736
Mill-Rose Laboratory
Ear, Nose, Throat · 14d
Cleared May 14, 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 29, 1996
MILL-ROSE BLIND MICROBIOLOGY BRUSH
K960880
Mill-Rose Laboratory
Ear, Nose, Throat · 56d
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 Aug 11, 1995
JEDMED LARYNGEAL SCOPE
K950925
Jedmed Instrument Co.
Ear, Nose, Throat · 163d
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