Product Code: KZH FDA class 2 21 CFR 880.6920

Introducer, Syringe Needle

General Hospital

The Syringe Needle Introducer is a device used to guide or assist in the insertion of a needle into a target site, such as a vein or body cavity, improving accuracy and reducing the risk of needle-stick injury or vessel damage during invasive procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZH, regulated under 21 CFR 880.6920, in the General Hospital medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KZH
Device Class: FDA class 2
Regulation Number: 880.6920
Medical Specialty: General Hospital
Review Panel: HO
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 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243232	GripMate	Dec 02, 2024	Substantially Equivalent	Synthon Hispania S.L.
K213429	AccuSert Needle Inserter	Oct 20, 2022	Substantially Equivalent	Emed Technologies Corporation
K163400	Orbit Inserter	Jul 26, 2017	Substantially Equivalent	Ypsomed AG
K160860	MiniMed Quick-serter	Sep 22, 2016	Substantially Equivalent	Medtronic Minimed
K141384	WHISPERJECT AUTOINJECTOR	Sep 12, 2014	Substantially Equivalent	Scandinavian Health Limited
K124026	LOBSTER AUTO-INJECTOR	Sep 13, 2013	Substantially Equivalent	Scandinavian Health Limited
K122837	AUTOJECT 2 FOR GLASSY SYRINGE	Oct 15, 2012	Substantially Equivalent	Owen Mumford, Ltd.
K111467	FLEXI-Q DV AND DVR AUTO-INJECTORS	Feb 09, 2012	Substantially Equivalent	Elcam Medical Acal
K082587	AUTO-SAFETY INJECTOR-2 (ASI-2)	Oct 02, 2008	Substantially Equivalent	Medical House Products Limited
K073476	COMPACT AUTO-SAFETY INJECTOR (CASI)	Mar 07, 2008	Substantially Equivalent	Medical House (Asi) Limited
K062339	DERMOTHERAP GUN	Feb 05, 2007	Substantially Equivalent	Dermoequipos S.R.L.
K063146	ACCU-CHEK LINKASSIST	Nov 27, 2006	Substantially Equivalent	Disetronic Medical Systems AG
K060141	DAI-R	Jun 12, 2006	Substantially Equivalent	Shl Medical, USA
K060389	CONFIDOSE IM AUTO-INJECTOR	Jun 06, 2006	Substantially Equivalent	Pharma-Pen, Inc.
K051667	EZ-JECT	Sep 27, 2005	Substantially Equivalent	Indolor, Ltd.
K050434	SHL DISPOSABLE AUTOINJECTOR	Jun 24, 2005	Substantially Equivalent	Shl Medical, USA
K033696	PERSONAL INJECTOR	Feb 16, 2005	Substantially Equivalent	Union Medico Aps
K042557	INNOJECT AUTO-INJECTOR	Nov 08, 2004	Substantially Equivalent	Innoject, Inc.
K032848	MEDSAFE SYSTEM INSERTER	Apr 12, 2004	Substantially Equivalent	Medsolve Technologies, LLC
K032425	INVISIJECT RESUSABLE AUTO-INJECTOR	Nov 05, 2003	Substantially Equivalent	Biogen
K021700	ANIMUS EZSERTER INFUSION SET INSERTER	Jun 04, 2002	Substantially Equivalent	Animas Corp.
K013362	AUTOJECT 2	Nov 13, 2001	Substantially Equivalent	Owen Mumford USA, Inc.
K010377	MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385	Apr 05, 2001	Substantially Equivalent	Minimed, Inc.
K000482	MODIFICATION TO AUTOJECT MINI	Mar 06, 2000	Substantially Equivalent	Owen Mumford, Ltd.
K993385	AUTOJET 2 (NON-FIXED NEEDLE TYPE)	Nov 10, 1999	Substantially Equivalent	Owen Mumford USA, Inc.
K992300	QUICK-SERTER, MODEL 395	Jul 29, 1999	Substantially Equivalent	Medtronic Minimed
K991680	SOFTINJECT	Jun 03, 1999	Substantially Equivalent	Androsystems Srl
K981266	AUTO-INJECTOR, SURE-INJECT 2000	Jul 14, 1998	Substantially Equivalent	Mighty Mo, Corp.
K974678	B-D AUTO-INJECTOR	May 29, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K974171	COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS	Dec 19, 1997	Substantially Equivalent	Teva Medical, Ltd.
K970479	MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300	Mar 31, 1997	Substantially Equivalent	Medtronic Minimed
K961309	POS-T-VAC ID-300	Jun 10, 1996	Substantially Equivalent	Pos-T-Vac, Inc.
K954729	PEN-INJECT 2.25	Jan 29, 1996	Substantially Equivalent	Scandinavian Health , Ltd.
K953735	AUTOJECT MINI	Nov 08, 1995	Substantially Equivalent	Owen Mumford USA, Inc.
K945660	AUTOJECT 2	Aug 11, 1995	Substantially Equivalent	Owen Mumford USA, Inc.
K951384	V-CATH PERCUTANEOUS INTRODUCER KIT	Jun 23, 1995	Substantially Equivalent	Hdc Corp.
K945473	V-CATH BREAKAWAY NEEDLE INTRODUCER	Jan 20, 1995	Substantially Equivalent	Hdc Corp.
K901803	SYRINGE NEEDLE INTRODUCER	Nov 20, 1990	Substantially Equivalent	Glaxo, Inc.
K883164	INSTAJECT II	Oct 04, 1988	Substantially Equivalent	Pavel Jordan & Associates, Inc.
K872233	INJECT-EASE	Sep 04, 1987	Substantially Equivalent	Palco Laboratories, Inc.
K870474	INSTAJECT	Mar 13, 1987	Substantially Equivalent	Pavel Jordan & Associates, Inc.
K862325	THE INJECTOR	Feb 27, 1987	Substantially Equivalent	American Medical Innovations, Inc.
K860284	DIAMATIC, AUTOMATIC INSULIN INJECTOR	Apr 07, 1986	Substantially Equivalent	Ulster Scientific, Inc.
K832847	MEDI-JECT	Feb 28, 1984	Substantially Equivalent	Jack H. Ritterskamp
K834440	INJECTION AIDE UNIT FOR DIAGETICS	Feb 04, 1984	Substantially Equivalent	Gottinger Co.
K832683	MONOJECT INJECTOMATIC	Sep 12, 1983	Substantially Equivalent	Sherwood Medical Co.
K790104	PISTORMATIC	May 14, 1979	Substantially Equivalent	Zelby, Burstein, Hartman & Burstein