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Panels › Gastroenterology, Urology › Product code FCG · Class 2

Biopsy Needle

Regulation 876.1075

0510(k)s in 12 months (133 all time)
0recalls in 12 months (54 all time)
51recalls that name a 510(k)
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Top companies in FCG

Company510(k)sRecalls
Boston Scientific Corp524
Bard Peripheral Vascular Inc08
Cook Ireland, Ltd.70
Medi-Globe Corp.70
Olympus Medical Systems Corp.70
Wilson-Cook Medical, Inc.51
Aomori Olympus Co., Ltd.05
Medtronic05
H.S. Hospital Service S.R.L.40
H.S. Hospital Services S.P.A.40
Decided510(k)Device and applicantCode
Oct 24, 2025K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
Olympus Medical Systems Corp., JP
FCG
Aug 21, 2025K250994ClearTip FNA and FNB Types
Finemedix Co., Ltd., KR
FCG
Jul 29, 2024K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
Cook Ireland, Ltd., IE
FCG
Aug 28, 2023K231422Precision GI
Limaca Medical, Ltd., IL
FCG
Jun 30, 2023K231267ClearTip
Finemedix Co., Ltd., KR
FCG
May 30, 2023K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
Cook Ireland, Ltd., IE
FCG
Mar 29, 2023K212423EndoDrill® Model X
Bibbinstruments AB, SE
FCG
Jul 6, 2022K212822Disposable Coaxial Biopsy Needle
Suzhou Leapmed Healthcare Corporation, CN
FCG
Jul 6, 2022K212819Disposable Biopsy Refill Needle
Suzhou Leapmed Healthcare Corporation, CN
FCG
May 20, 2021K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial Hig
Cook Ireland, Ltd., IE
FCG
Jan 29, 2020K191472Biopsy Needle
Ushare Medical, Inc., CN
FCG
Dec 18, 2018K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Apriomed AB, SE
FCG
Nov 15, 2018K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
Olympus Medical Systems Corp., JP
FCG
Nov 1, 2018K180363Clear-Tip EUS-FNA
Finemedix Co., Ltd., KR
FCG
Oct 31, 2018K181994Single Use Aspiration Needle NA-U201H
Olympus Medical Systems Corp., JP
FCG
Jun 8, 2018K180449Single Use Aspiration Needle NA-U200H
Olympus Medical Systems Corp., JP
FCG
Apr 26, 2018K180037Beacon EUS Access System
Covidien, LLC
FCG
Dec 12, 2017K171956Sterile Endoscope Biopsy Sampling Needle
Changzhou Detain Medical Devices Co., Ltd., CN
FCG
Aug 4, 2017K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
Wilson-Cook Medical, Inc.
FCG
Jun 14, 2017K160890Howell Biliary Introducer Needle
Wilson-Cook Medical, Inc.
FCG
Sep 2, 2016K160423Perineologic Access Needle
Corbin Clinical Resources, LLC
FCG
Mar 22, 2016K160098Single Use Aspiration Needle NA-U401SX
Olympus Medical Systems Corp., JP
FCG
Mar 21, 2016K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound
Cook Ireland, Ltd., IE
FCG
Nov 20, 2015K151738Single Use Aspiration Needle NA-U200H
Olympus Medical Systems Corp., JP
FCG
Oct 22, 2015K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation
FCG
Aug 7, 2015K151373Corvocet Coaxial Introducer
Merit Medical Systems, Inc.
FCG
May 1, 2015K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
Covidien, LLC( Formerly Beacon Endoscopic Corp.)
FCG
Dec 19, 2014K142688Echotip Procore HD Ultrasound Biopsy Needle
Cook Ireland, Ltd., IE
FCG
Oct 10, 2014K131925HS NOTA
H.S. Hospital Services S.P.A.
FCG
Oct 6, 2014K141894SHARKCORE FINE NEEDLE BIOPSY SYSTEM
Covidien, LLC( Formerly Beacon Endoscopic Corp.)
FCG
May 15, 2014K133763SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
Medi-Globe Corporation
FCG
Mar 25, 2014K140137SAFETY BIOPSY NEEDLE SYSTEM
Pfm Medical, Inc.
FCG
Nov 20, 2013K133008BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
Beacon Endoscopic
FCG
Jul 27, 2011K103694TISSUE SAMPLING NEEDLE
United States Endoscopy Group, Inc.
FCG
Dec 30, 2010K103668BNX FINE NEEDLE ASPIRATION SYSTEM
Boston Endoscopic Engineering
FCG
Mar 30, 2010K100712RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
Boston Scientific Corporation
FCG
Jan 21, 2010K093195ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
Cook Ireland, Ltd., IE
FCG
Nov 2, 2009K092359ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
Cook Ireland, Ltd., IE
FCG
May 8, 2009K091257MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
Medi-Globe Corporation
FCG
Mar 20, 2009K083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
Medi-Globe Corporation
FCG
Feb 6, 2009K083330ECHOTIP ULTRA ULTRASOUND NEEDLE
Cook Endoscopy
FCG
Jul 22, 2008K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
B-K Medical Aps, DK
FCG
Dec 21, 2007K073399TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
Envisioneering, LLC
FCG
May 30, 2007K062979THYROSAMPLER
Acd Medical Innovation Corp.
FCG
Mar 7, 2007K070179TROKABONE, TROKABONE STERNAL
PAJUNK GmbH Medizintechnologie, DE
FCG
Jan 31, 2007K070129SONOTIP II ULTRASOUND NEEDLE SYSTEM
Medi-Globe Corporation
FCG
Jul 27, 2005K051506MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
Sterylab S.R.L.
FCG
Jul 13, 2005K050135K-C HEMOSTATIC BIOPSY SYSTEM
Bioengineering Consultants , Ltd.
FCG
Jun 16, 2005K051247SONOTIP II ULTRASOUND NEEDLE SYSTEM
Medi-Globe Corp.
FCG
May 12, 2005K050503SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
Olympus Medical Systems Corporation
FCG

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