Product Code: FCG FDA class 2 21 CFR 876.1075

Biopsy Needle

Gastroenterology, Urology

The Biopsy Needle (product code FCG) is a hollow needle used to obtain tissue core samples from the gastrointestinal or genitourinary tract for histological or cytological analysis. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

133

FEI Numbers

128

Registration Numbers

128

Unique Applicants

Years Active

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Basic Information

Product Code: FCG
Device Class: FDA class 2
Regulation Number: 876.1075
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 133 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252646	Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)	Oct 24, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K250994	ClearTip FNA and FNB Types	Aug 21, 2025	Substantially Equivalent	Finemedix Co., Ltd.
K241209	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)	Jul 29, 2024	Substantially Equivalent	Cook Ireland, Ltd.
K231422	Precision GI	Aug 28, 2023	Substantially Equivalent	Limaca Medical, Ltd.
K231267	ClearTip	Jun 30, 2023	Substantially Equivalent	Finemedix Co., Ltd.
K230909	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)	May 30, 2023	Substantially Equivalent	Cook Ireland, Ltd.
K212423	EndoDrill® Model X	Mar 29, 2023	Substantially Equivalent	Bibbinstruments AB
K212822	Disposable Coaxial Biopsy Needle	Jul 06, 2022	Substantially Equivalent	Suzhou Leapmed Healthcare Corporation
K212819	Disposable Biopsy Refill Needle	Jul 06, 2022	Substantially Equivalent	Suzhou Leapmed Healthcare Corporation
K210476	EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle	May 20, 2021	Substantially Equivalent	Cook Ireland, Ltd.
K191472	Biopsy Needle	Jan 29, 2020	Substantially Equivalent	Ushare Medical, Inc.
K181756	Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle	Dec 18, 2018	Substantially Equivalent	Apriomed AB
K180668	Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N	Nov 15, 2018	Substantially Equivalent	Olympus Medical Systems Corp.
K180363	Clear-Tip EUS-FNA	Nov 01, 2018	Substantially Equivalent	Finemedix Co., Ltd.
K181994	Single Use Aspiration Needle NA-U201H	Oct 31, 2018	Substantially Equivalent	Olympus Medical Systems Corp.
K180449	Single Use Aspiration Needle NA-U200H	Jun 08, 2018	Substantially Equivalent	Olympus Medical Systems Corp.
K180037	Beacon EUS Access System	Apr 26, 2018	Substantially Equivalent	Covidien, LLC
K171956	Sterile Endoscope Biopsy Sampling Needle	Dec 12, 2017	Substantially Equivalent	Changzhou Detain Medical Devices Co., Ltd.
K171596	ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle	Aug 04, 2017	Substantially Equivalent	Wilson-Cook Medical, Inc.
K160890	Howell Biliary Introducer Needle	Jun 14, 2017	Substantially Equivalent	Wilson-Cook Medical, Inc.
K160423	Perineologic Access Needle	Sep 02, 2016	Substantially Equivalent	Corbin Clinical Resources, LLC
K160098	Single Use Aspiration Needle NA-U401SX	Mar 22, 2016	Substantially Equivalent	Olympus Medical Systems Corp.
K160229	Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle	Mar 21, 2016	Substantially Equivalent	Cook Ireland, Ltd.
K151738	Single Use Aspiration Needle NA-U200H	Nov 20, 2015	Substantially Equivalent	Olympus Medical Systems Corp.
K151895	Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle	Oct 22, 2015	Substantially Equivalent	Boston Scientific Corporation
K151373	Corvocet Coaxial Introducer	Aug 07, 2015	Substantially Equivalent	Merit Medical Systems, Inc.
K150891	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	May 01, 2015	Substantially Equivalent	Covidien, LLC( Formerly Beacon Endoscopic Corp.)
K142688	Echotip Procore HD Ultrasound Biopsy Needle	Dec 19, 2014	Substantially Equivalent	Cook Ireland, Ltd.
K131925	HS NOTA	Oct 10, 2014	Substantially Equivalent	H.S. Hospital Services S.P.A.
K141894	SHARKCORE FINE NEEDLE BIOPSY SYSTEM	Oct 06, 2014	Substantially Equivalent	Covidien, LLC( Formerly Beacon Endoscopic Corp.)
K133763	SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM	May 15, 2014	Substantially Equivalent	Medi-Globe Corporation
K140137	SAFETY BIOPSY NEEDLE SYSTEM	Mar 25, 2014	Substantially Equivalent	Pfm Medical, Inc.
K133008	BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,	Nov 20, 2013	Substantially Equivalent	Beacon Endoscopic
K103694	TISSUE SAMPLING NEEDLE	Jul 27, 2011	Substantially Equivalent	United States Endoscopy Group, Inc.
K103668	BNX FINE NEEDLE ASPIRATION SYSTEM	Dec 30, 2010	Substantially Equivalent	Boston Endoscopic Engineering
K100712	RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE	Mar 30, 2010	Substantially Equivalent	Boston Scientific Corporation
K093195	ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O	Jan 21, 2010	Substantially Equivalent	Cook Ireland, Ltd.
K092359	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A	Nov 02, 2009	Substantially Equivalent	Cook Ireland, Ltd.
K091257	MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM	May 08, 2009	Substantially Equivalent	Medi-Globe Corporation
K083802	SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025	Mar 20, 2009	Substantially Equivalent	Medi-Globe Corporation
K083330	ECHOTIP ULTRA ULTRASOUND NEEDLE	Feb 06, 2009	Substantially Equivalent	Cook Endoscopy
K081323	BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818	Jul 22, 2008	Substantially Equivalent	B-K Medical Aps
K073399	TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE	Dec 21, 2007	Substantially Equivalent	Envisioneering, LLC
K062979	THYROSAMPLER	May 30, 2007	Substantially Equivalent	Acd Medical Innovation Corp.
K070179	TROKABONE, TROKABONE STERNAL	Mar 07, 2007	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K070129	SONOTIP II ULTRASOUND NEEDLE SYSTEM	Jan 31, 2007	Substantially Equivalent	Medi-Globe Corporation
K051506	MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY	Jul 27, 2005	Substantially Equivalent	Sterylab S.R.L.
K050135	K-C HEMOSTATIC BIOPSY SYSTEM	Jul 13, 2005	Substantially Equivalent	Bioengineering Consultants , Ltd.
K051247	SONOTIP II ULTRASOUND NEEDLE SYSTEM	Jun 16, 2005	Substantially Equivalent	Medi-Globe Corp.
K050503	SINGLE USE ASPIRATION NEEDLE NA-201SX-4022	May 12, 2005	Substantially Equivalent	Olympus Medical Systems Corporation
K050120	EASY CORE BIOPSY SYSTEM II	Feb 08, 2005	Substantially Equivalent	Boston Scientific Corp
K040893	EASY CORE BIOPSY SYSTEM	May 06, 2004	Substantially Equivalent	Boston Scientific Corp
K024120	MODIFICATION TO TEMNO BIOPSY NEEDLES	Jan 15, 2003	Substantially Equivalent	Allegiance Healthcare Corp.
K023272	DISPOSABLE ASPIRATION NEEDLE NA-200H	Dec 23, 2002	Substantially Equivalent	The Olympus Optical Co.
K021847	BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES	Sep 03, 2002	Substantially Equivalent	Biopsy Sciences, LLC
K021525	TOPCUT	Jul 12, 2002	Substantially Equivalent	H.S. Hospital Service S.R.L.
K013109	SONOPSY	Mar 12, 2002	Substantially Equivalent	Hakko Medical Co., Ltd.
K013071	SECURCUT ASPIRATION BIOPSY NEEDLE	Dec 12, 2001	Substantially Equivalent	H.S. Hospital Services S.P.A.
K013070	JAMSHIDI BIOPSY NEEDLE	Dec 12, 2001	Substantially Equivalent	H.S. Hospital Services S.P.A.
K013069	BIOSPEED	Dec 12, 2001	Substantially Equivalent	H.S. Hospital Services S.P.A.
K012864	INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836	Oct 24, 2001	Substantially Equivalent	Boston Scientific Corp
K013356	WILSON-COOK ULTRASOUND BIOPSY NEEDLE	Oct 19, 2001	Substantially Equivalent	Wilson-Cook Medical, Inc.
K012358	CHIBA NEEDLE	Oct 15, 2001	Substantially Equivalent	Ispg, Inc.
K011075	EASYBELL	Jun 27, 2001	Substantially Equivalent	Biopsybell S.A.S.
K011270	AUTOMATED CORE BIOPSY DEVICE	Jun 22, 2001	Substantially Equivalent	Promex, Inc.
K002947	BIOMOL ASPIRATION BIOPSY NEEDLE	Dec 19, 2000	Substantially Equivalent	H.S. Hospital Service S.R.L.
K002946	SILENT BIOPSY NEEDLE	Dec 19, 2000	Substantially Equivalent	H.S. Hospital Service S.R.L.
K002944	PRECISA BIOPSY NEEDLE	Dec 19, 2000	Substantially Equivalent	H.S. Hospital Service S.R.L.
K991672	OLYMPUS NA-10J-KB ASPIRATION NEEDLE	Nov 03, 1999	Substantially Equivalent	Olympus America, Inc.
K990220	MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM	Mar 31, 1999	Substantially Equivalent	Medi-Globe Corp.
K983218	N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE	Nov 06, 1998	Substantially Equivalent	Avid N.I.T., Inc.
K981889	WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE	Jul 31, 1998	Substantially Equivalent	Worldwide Medical Technologies, LLC
K963565	MRI NEEDLES	Jul 14, 1997	Substantially Equivalent	Cook, Inc.
K971842	COAXIAL NEEDLE	Jun 20, 1997	Substantially Equivalent	United States Endoscopy Group, Inc.
K970563	OLYMPUS NA-10J-1 ASPIRATION NEEDLE	Apr 11, 1997	Substantially Equivalent	Olympus America, Inc.
K963894	SMARTGUIDE	Mar 11, 1997	Substantially Equivalent	Ferguson Medical
K961897	WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE	Jan 29, 1997	Substantially Equivalent	Wilson-Cook Medical, Inc.
K962570	ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE	Nov 27, 1996	Substantially Equivalent	Gallini Intl., Inc.
K962569	BIOMID BONE MARROW BIOPSY NEEDLE	Nov 27, 1996	Substantially Equivalent	Gallini Intl., Inc.
K962568	ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES	Nov 25, 1996	Substantially Equivalent	Gallini Intl., Inc.
K962905	TX BIOPSY NEEDLE	Oct 11, 1996	Substantially Equivalent	Gallini S.R.L.
K961185	DAUM BIOPSYNEEDLE	Apr 30, 1996	Substantially Equivalent	Ferguson Medical
K960317	LAURUS NEEDLE CORE BIOPSY SYSTEM	Mar 15, 1996	Substantially Equivalent	Laurus Medical Corp.
K943304	3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY	Dec 20, 1995	Substantially Equivalent	Olympus America, Inc.
K951421	GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES	Nov 16, 1995	Substantially Equivalent	Global Medical Products, Ltd.
K954596	PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM	Oct 07, 1995	Substantially Equivalent	Promedical , Ltd.
K954231	AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT	Sep 22, 1995	Substantially Equivalent	Promex, Inc.
K954155	GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE	Sep 12, 1995	Substantially Equivalent	Promex, Inc.
K941722	FNA BIOPSY NEEDLE	May 22, 1995	Substantially Equivalent	Betta Medical, Inc.
K951598	PRO-B BIOPSY NEEDLE	Apr 21, 1995	Substantially Equivalent	Promedical , Ltd.
K950982	B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE	Apr 04, 1995	Substantially Equivalent	B. Braun of America, Inc.
K950810	RUTNER BIOPSY DEVICE	Mar 06, 1995	Substantially Equivalent	Cook Urological, Inc.
K935844	GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA	Feb 13, 1995	Substantially Equivalent	Medi-Globe Corp.
K945813	BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP	Feb 07, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K945921	ECHO STAR NEEDLE SET	Feb 01, 1995	Substantially Equivalent	Ideamatrix
K945146	CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE	Dec 21, 1994	Substantially Equivalent	Promex, Inc.
K944944	CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE	Dec 21, 1994	Substantially Equivalent	Promedical , Ltd.
K945133	MODIFIED BIOPSY NEEDLE	Nov 09, 1994	Substantially Equivalent	Biopsys Medical, Inc.
K941563	THE BIOPSY TOOL	Sep 26, 1994	Substantially Equivalent	Citation Medical Corp.
K934256	GLOBAL MEDICAL CUTTING BIOPSY NEEDLE	Mar 28, 1994	Substantially Equivalent	Global Medical Prods, Inc.
K936194	COAXIAL BIOPSY NEEDLE	Mar 22, 1994	Substantially Equivalent	Bard Gynecology and Radiology
K915801	BIP-COAX-SYSTEM	Mar 11, 1994	Substantially Equivalent	Uni-Quatro Industries Canada, Inc.
K934370	BIP BIOPSY NEEDLE MODIFICATION	Mar 07, 1994	Substantially Equivalent	Bip USA, Inc.
K934356	WILSON-COOK GI ASPIRATION NEEDLE	Jan 07, 1994	Substantially Equivalent	Wilson-Cook Medical, Inc.
K926559	PROACT BIOPSY NEEDLE ENCHANCEMENTS	Mar 22, 1993	Substantially Equivalent	Proact, Ltd.
K924271	CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES	Nov 23, 1992	Substantially Equivalent	Core Medical, Inc.
K914732	CORE MEDICAL BIOPSY NEEDLE	Jan 07, 1992	Substantially Equivalent	Core Medical, Inc.
K910720	BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER	Jun 10, 1991	Substantially Equivalent	C.R. Bard, Inc.
K911397	HYPODERMIC NEEDLES, SINGLE LUMEN	May 20, 1991	Substantially Equivalent	Popper & Sons, Inc.
K905556	HIGH SPEED CORE CUT BIOPSY GUN	Mar 08, 1991	Substantially Equivalent	Uni-Quatro Industries Canada, Inc.
K902320	BAUER FLEXI-TEMNO BIOPSY NEEDLE	Oct 01, 1990	Substantially Equivalent	Proact, Ltd.
K902319	BAUER TEMNO BIOPSY NEEDLE	Sep 06, 1990	Substantially Equivalent	Proact, Ltd.
K896932	INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE	Jun 22, 1990	Substantially Equivalent	The Witmoore Group, Inc.
K895725	BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES	Nov 06, 1989	Substantially Equivalent	Interson Corp.
K895897	MANAN PROSTATIC BIOPSY NEEDLE	Oct 18, 1989	Substantially Equivalent	Manan Medical Products, Inc.
K892068	TRT (ACUSON) NEEDLE GUIDE KIT, STERILE	Aug 04, 1989	Substantially Equivalent	Amedic USA
K891777	PRO-CUT BIOPSY NEEDLE	May 04, 1989	Substantially Equivalent	Teknar, Inc.
K890327	BIOPSY NEEDLE GUIDE ATTACHMENT	Mar 08, 1989	Substantially Equivalent	Elscint, Inc.
K890203	ADMS BIOPSY NEEDLE	Mar 08, 1989	Substantially Equivalent	Advanced Diagnostic Medical Systems, Inc.
K882549	ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.	Jul 21, 1988	Substantially Equivalent	Acuson Corp.
K871467	BIOPSY NEEDLE GUIDE KIT, STERILE	Aug 21, 1987	Substantially Equivalent	Amedic USA
K854404	ROTEX SCREW BIOPSY NEEDLE	Dec 02, 1985	Substantially Equivalent	Meadox Surgimed, Inc.
K854289	MEDSURG ULTRASOUND BIOPSY TRAY	Nov 26, 1985	Substantially Equivalent	Medsurg Industries, Inc.
K844993	COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720	Feb 28, 1985	Substantially Equivalent	Omnis Surgical, Inc.
K840144	YAG LASER 8000 GASTROINTESTINAL BLEE	May 18, 1984	Substantially Equivalent	Cooper Medical Corp.
K840354	MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE	Mar 12, 1984	Substantially Equivalent	Sherwood Medical Co.
K840168	WESTERMAN-JENSEN BIOPSY NEEDLE	Mar 12, 1984	Substantially Equivalent	Popper & Sons, Inc.
K840157	MILLEREISEN CURVED BIOPSY NEEDLE	Mar 12, 1984	Substantially Equivalent	Preventive Medicine Institute
K834249	MONOJECT SOFT TISSUE BIOPSY NEEDLE	Mar 12, 1984	Substantially Equivalent	Sherwood Medical Co.
K800420	ADT PERCUTANEOUS NON-DISP. NEEDLE	Mar 25, 1980	Substantially Equivalent	A.D.T. Lab Industries
K800419	ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL	Mar 25, 1980	Substantially Equivalent	A.D.T. Lab Industries
K800416	ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)	Mar 25, 1980	Substantially Equivalent	A.D.T. Lab Industries
K771108	NEEDLE, CHIBA UNIVERSITY	Jul 29, 1977	Substantially Equivalent	Johannah Medical Services, Inc.