Product Code: FIE FDA class 2 21 CFR 876.5540

Needle, Fistula

Gastroenterology, Urology

The Fistula Needle is a large-bore needle used to access an arteriovenous fistula or graft in patients undergoing hemodialysis, enabling connection to the dialysis circuit. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FIE, regulated under 21 CFR 876.5540, within the Gastroenterology, Urology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FIE
Device Class: FDA class 2
Regulation Number: 876.5540
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 79 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251877	JMS CAVEO A.V. Fistula Needle Set	Aug 15, 2025	Substantially Equivalent	JMS North America Corporation
K213015	DORA Disposable A.V. Fistula Needle Sets	Apr 08, 2022	Substantially Equivalent	Bain Medical Equipment (Guangzhou) Co., Ltd.
K171505	Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)	May 17, 2018	Substantially Equivalent	Dimesol, Inc.
K163025	DORA Disposable A.V. Fistula Needle Sets	Jul 20, 2017	Substantially Equivalent	Bain Medical Equipment (Guangzhou) Co., Ltd.
K151017	JMS Harmony A.V. Fistula Needle Set	May 13, 2015	Substantially Equivalent	JMS North America Corporation
K131950	ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET	Jan 16, 2015	Substantially Equivalent	Summit International Medical Technologies, Inc.
K142564	JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)	Dec 23, 2014	Substantially Equivalent	JMS North America Corporation
K134019	MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO	Sep 11, 2014	Substantially Equivalent	Nxstage Medical, Inc.
K112734	APLAN A.V. FISTULA NEEDLE SET	Apr 24, 2012	Substantially Equivalent	Aplan Well Enterprise Co., Ltd.
K112178	JMS APHERESIS NEEDLE SET WINGEATER(R) V2	Oct 27, 2011	Substantially Equivalent	JMS North America Corporation
K111948	WINGEATER V2	Oct 24, 2011	Substantially Equivalent	JMS North America Corporation
K110157	SYSLOC MINI V3	Feb 11, 2011	Substantially Equivalent	JMS North America Corporation
K100520	NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER	Mar 17, 2010	Substantially Equivalent	Nipro Medical Corporation
K093637	JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300	Feb 09, 2010	Substantially Equivalent	Jms North America Corp.
K093985	NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE	Jan 22, 2010	Substantially Equivalent	Nipro Medical Corp.
K082882	A.V. FISTULA BLUNT NEEDLE SET	Jan 21, 2009	Substantially Equivalent	Jms North America Corp.
K062953	MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE	Feb 12, 2007	Substantially Equivalent	Medisystems Corp.
K063368	NIPRO BIOHOLE NEEDLE	Feb 05, 2007	Substantially Equivalent	Nipro Medical Corp.
K063721	NIPRO SAFETOUCH II GAMMA	Jan 12, 2007	Substantially Equivalent	Nipro Medical Corp.
K052267	SUPERCATH V	Oct 27, 2006	Substantially Equivalent	Togo Medikit Co., Ltd.
K051814	JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET	Aug 04, 2005	Substantially Equivalent	Jms North America Corp.
K040247	PLUME SAFETY AVF NEEDLE	Mar 03, 2004	Substantially Equivalent	Jms North America Corp.
K023162	FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS	Mar 20, 2003	Substantially Equivalent	Fresenius Medical Care
K013384	SHARGHP A.V. FISTULA NEEDLE SET	Jan 07, 2002	Substantially Equivalent	Shargh Pharmaceutical Co., Inc.
K013037	EXCEL A.V FISUTAL NEEDLE SET	Dec 07, 2001	Substantially Equivalent	Exelint Intl. Co.
K002352	JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE	Sep 06, 2001	Substantially Equivalent	Jms Co., Ltd.
K003123	RENAX A.V. FISTULA NEEDLE SETS	May 04, 2001	Substantially Equivalent	Sunder Biomedical Tech. Co., Ltd.
K002813	NIPRO SAFETOUCH SAFETY FISTULA NEEDLE	Nov 21, 2000	Substantially Equivalent	Nipro Medical Corp.
K001496	A.V. FISTULA NEEDLE	Aug 01, 2000	Substantially Equivalent	Exelint International, Co.
K000845	MODIFICATION TO JMS A.V. FISTULA NEEDLE SET	Apr 10, 2000	Substantially Equivalent	Jms Co., Ltd.
K000843	MODIFICATION TO JMS APHERESIS NEEDLE	Apr 10, 2000	Substantially Equivalent	Jms Co., Ltd.
K990803	MEDISYSTEMS BUTTONHOLE NEEDLE SETS	Jan 06, 2000	Substantially Equivalent	Medisystems Corp.
K993118	BIOTEQUE A.V. FISTULA NEEDLE SET	Dec 17, 1999	Substantially Equivalent	Bioteque Corp.
K992653	SHELLY PROTECTED AV FISTULA NEEDLE	Oct 27, 1999	Substantially Equivalent	Diasol, Inc.
K990510	JMS APHERESIS NEEDLE	Aug 30, 1999	Substantially Equivalent	Jms Co., Ltd.
K990470	JMS A. V. FISTULA NEEDLE SET	Aug 30, 1999	Substantially Equivalent	Jms Co., Ltd.
K991623	NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA	Aug 09, 1999	Substantially Equivalent	Nipro Medical Corp.
K974902	JMS APHERESIS NEEDLE	Mar 30, 1998	Substantially Equivalent	Jms Co., Ltd.
K970962	JMS AV FISTULA NEEDLE	Aug 07, 1997	Substantially Equivalent	Jms Co., Ltd.
K955182	NIPRO ARTERIAL VENOUS FISTULA NEEDLE	Jun 04, 1996	Substantially Equivalent	Nissho Corp.
K945850	BRAUN DIACAN(R) FISTULA NEEDLES	Oct 06, 1995	Substantially Equivalent	B. Braun of America, Inc.
K932074	MEDISYSTEMS APHERESIS NEEDLE WITH GUARD	Feb 18, 1994	Substantially Equivalent	Medisystems Corp.
K915174	JMS APHERESIS NEEDLE	Mar 02, 1993	Substantially Equivalent	Jms Co., Ltd.
K903440	VIVAMED FISTULA NEEDLE	Apr 20, 1992	Substantially Equivalent	S.S. Ent.
K911199	JMS AV FISTULA NEEDLES	Aug 28, 1991	Substantially Equivalent	Jms Co., Ltd.
K910734	MEDISYSTEMS HEMODIALYSIS FISTULA SET	Jun 20, 1991	Substantially Equivalent	Medisystems Corp.
K902564	NEEDLE, DIALYSIS	Mar 01, 1991	Substantially Equivalent	Gainor Medical Europe, Ltd.
K903945	EXEL A-V FISTULA SET	Nov 20, 1990	Substantially Equivalent	Exel Intl.
K900125	ARTERIOVENOUS FISTULA SETS	Jan 31, 1990	Substantially Equivalent	Baxter Healthcare Corp
K891062	TERUMO AV FISTULA NEEDLE SET	Jun 22, 1989	Substantially Equivalent	Terumo Medical Corp.
K880726	JMS APHERESIS NEEDLE	Mar 16, 1988	Substantially Equivalent	Jms Co., Ltd.
K862002	MEDISYSTEMS PHERESIS NEEDLE	Jun 27, 1986	Substantially Equivalent	Medisystems Corp.
K854773	SUPERCATH A.V. FISTULA	Apr 08, 1986	Substantially Equivalent	Togo Medikit Co., Ltd.
K860789	JMD AV FISTULA NEEDLE (MODIFICATION)	Mar 18, 1986	Substantially Equivalent	Jms Co., Ltd.
K860449	MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE	Feb 26, 1986	Substantially Equivalent	Top Corp.
K860241	JMS AV FISTULA NEEDLE	Feb 05, 1986	Substantially Equivalent	Jms Co., Ltd.
K854951	PLUME Y SET	Jan 08, 1986	Substantially Equivalent	Hospal Medical Corp.
K851453	HOSPAL FISTULA NEEDLE	Apr 29, 1985	Substantially Equivalent	Hospal Medical Corp.
K844343	TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE	Jan 08, 1985	Substantially Equivalent	Top Surgical Manufacturers Co.
K832136	DUAL FLOW NEEDLE	Oct 14, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K812621	DELTA-A.V. FISTULA CANNULATION SET	Sep 24, 1981	Substantially Equivalent	Amisco Trading Corp.
K811838	MEDISYSTEMS FISTULA NEEDLE	Sep 08, 1981	Substantially Equivalent	Medisystems Corp.
K802956	GAMBRO A-V FISTULA NEEDLE SET	Dec 22, 1980	Substantially Equivalent	Gambro, Inc.
K801966	HEMO-CATH II KIDNEY DIALYSIS CATHETER	Sep 26, 1980	Substantially Equivalent	Medical Components, Inc.
K801618	ARGYLE A-V MEDI-WING HEMODIALYSIS SET	Aug 13, 1980	Substantially Equivalent	Sherwood Medical Co.
K801632	THE BELLCO FISTULA NEEDLES	Aug 04, 1980	Substantially Equivalent	Bellco Artifidial Organ Spec., Inc.
K791490	UNIPUNCTURE CATHETER	Oct 26, 1979	Substantially Equivalent	Hospal Medical Corp.
K791489	VITAL CATHETER	Oct 26, 1979	Substantially Equivalent	Hospal Medical Corp.
K782021	A.V. FISTULA NEEDLE SET	Mar 21, 1979	Substantially Equivalent	Cordis Corp.
K772362	AVF SET FOR SINGLE NEEDLE HEMODIALYSIS	Mar 17, 1978	Substantially Equivalent	Terumo America, Inc.
K771495	A.V. FISTULA NEEDLE SET (#361)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771494	A.V. FISTULA NEEDLE SET (354)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771493	A.V. FISTULA NEEDLE SET (#341)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771492	A.V. FISTULA NEEDLE SET (#351)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771491	A.V. FISTULA NEEDLE SET (#364)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771490	A.V. FISTULA NEEDLE SET (#344)	Aug 16, 1977	Substantially Equivalent	Sorensen Research
K771206	AV FISTULA NEEDLE SET	Jul 15, 1977	Substantially Equivalent	Terumo America, Inc.
K770864	HEMODIALYSIS FISTULA SET	Jun 24, 1977	Substantially Equivalent	Venospital, Inc.
K770699	NEEDLE SET, A-V FISTULA	Jun 14, 1977	Substantially Equivalent	Medical Disposables Intl., Inc.