ClearanceBrief
Panels › Ear, Nose, Throat › Product code KTI · Class 2

Bronchoscope Accessory

Regulation 874.4680

4510(k)s in 12 months (34 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in KTI

Company510(k)sRecalls
Acclarent, Inc.28
Olympus Surgical Technologies America40
Boston Scientific Corp30
Olympus Medical Systems Corp.30
Bryan Medical, Inc.11
Merit Medical Systems, Inc.20
Serpex Medical, Inc.20
Alton (Shanghai) Medical Instruments Co., Ltd.10
American Endoscopy, Inc.10
Asthmatx, Inc.10
Decided510(k)Device and applicantCode
Jul 24, 2026K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasou
Cook Ireland, Ltd., IE
KTI
Apr 16, 2026K251478ClearTip TBNA Type
Finemedix Co., Ltd., KR
KTI
Mar 12, 2026K254040LungFlow Basket Catheter
Free Flow Medical, Inc.
KTI
Dec 19, 2025K251402LIA-1 Catheter (542-1)
Leadoptik, Inc.
KTI
Oct 8, 2025K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Serpex Medical, Inc.
KTI
Jul 29, 2025K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
Olympus Medical Systems Corporation, JP
KTI
Mar 31, 2025K250263Disposable Grasping Forceps FG-52D/FG-54D
Olympus Medical Systems Corp., JP
KTI
Mar 4, 2025K241679Disposable Cytology Brush (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
KTI
Nov 15, 2023K231818METIC™- Airway Balloon Catheter
M/S Meril Life Sciences Pvt. , Ltd., IN
KTI
Sep 25, 2023K230778EndoCore
Praxis Medical, LLC
KTI
May 11, 2023K230280ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
Ga Health Company Limited, HK
KTI
Mar 1, 2023K222187Multistage Balloon Dilatation Catheter
Dongguan TT Medical, Inc., CN
KTI
Aug 25, 2022K221206Compass Steerable Needle
Serpex Medical, Inc.
KTI
Jul 20, 2022K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Micro-Tech (Nanjing) Co., Ltd., CN
KTI
Mar 8, 2022K213434Elation Pulmonary Balloon Dilation Catheter
Merit Medical Systems, Inc.
KTI
Nov 24, 2021K211894Trachealator
Disa Medinotec, ZA
KTI
Mar 18, 2020K193517ViziShot 2 FLEX
Olympus Surgical Technologies America
KTI
Dec 10, 2019K190239Single Use Aspiration Needle
Olympus Medical Systems Corp., JP
KTI
Jul 3, 2018K181193PeriView FLEX
Olympus Surgical Technologies America
KTI
Sep 21, 2017K171232PeriView FLEX
Olympus Surgical Technologies America
KTI
Jun 23, 2017K170759CRE Pulmonary Balloon Dilatation Catheter
Boston Scientific Corporation
KTI
Apr 6, 2017K163469ViziShot 2 FLEX
Olympus Surgical Technologies America
KTI
Sep 1, 2016K161392Elation Pulmonary Balloon Dilation
Merit Medical Systems, Inc.
KTI
Jul 27, 2016K153484Dillard Airway Dilatation System
Intuit Medical Products, LLC
KTI
Feb 19, 2016K152922ViziShot FLEX
Spiration, Inc.
KTI
Sep 17, 2015K151522DEFENDO Bronchoscopy Suction Valve
Medivators, Inc.
KTI
Jun 25, 2015K150951aeris Balloon Dialation Catheter
Bryan Medical, Inc.
KTI
Mar 31, 2011K110218INSPIRA AIR BALLOON DILATION SYSTEM
Acclarent, Inc.
KTI
Jun 12, 2009K090660AIRWAY BALLOON CATHETER INFLATION DEVICE
Acclarent, Inc.
KTI
Oct 20, 2008K082174Y-ADAPTER
Asthmatx, Inc.
KTI
Nov 18, 2002K023337CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
Boston Scientific Corp
KTI
Apr 5, 2002K020765MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
Boston Scientific Corp
KTI
Apr 25, 1984K833491ENDO BITE BLOCK
American Endoscopy, Inc.
KTI
Aug 14, 1978K781365SPARTA BRONCHIAL BRUSH
Sparta Instrument Corp.
KTI

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