KTI · Class II · 21 CFR 874.4680

FDA Product Code KTI: Bronchoscope Accessory

Under FDA product code KTI, bronchoscope accessories are cleared for use with bronchoscopic procedures in pulmonology and critical care.

These accessories include biopsy forceps, brushes, needles, suction catheters, and balloon catheters passed through the working channel of a bronchoscope to perform tissue sampling, foreign body removal, and therapeutic interventions within the airways.

KTI devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Olympus Surgical Technologies America, Serpex Medical, Inc. and Boston Scientific Corp.

34
Total
34
Cleared
133d
Avg days
1978
Since
34 devices
25–34 of 34
Cleared Feb 19, 2016
ViziShot FLEX
K152922
Spiration, Inc.
Ear, Nose, Throat · 140d
Cleared Sep 17, 2015
DEFENDO Bronchoscopy Suction Valve
K151522
Medivators, Inc.
Ear, Nose, Throat · 104d
Cleared Jun 25, 2015
aeris Balloon Dialation Catheter
K150951
Bryan Medical, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
K110218
Acclarent, Inc.
Ear, Nose, Throat · 65d
Cleared Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660
Acclarent, Inc.
Ear, Nose, Throat · 92d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
K023337
Boston Scientific Corp
Ear, Nose, Throat · 42d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared Apr 25, 1984
ENDO BITE BLOCK
K833491
American Endoscopy, Inc.
Ear, Nose, Throat · 201d