FDA 510(k) Applications for Medical Device Product Code "KZH"
(Introducer, Syringe Needle)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991680 | ANDROSYSTEMS SRL | SOFTINJECT | 06/03/1999 |
| K021700 | ANIMAS CORP. | ANIMUS EZSERTER INFUSION SET INSERTER | 06/04/2002 |
| K974678 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | B-D AUTO-INJECTOR | 05/29/1998 |
| K032425 | BIOGEN | INVISIJECT RESUSABLE AUTO-INJECTOR | 11/05/2003 |
| K062339 | DERMOEQUIPOS S.R.L. | DERMOTHERAP GUN | 02/05/2007 |
| K063146 | DISETRONIC MEDICAL SYSTEMS AG | ACCU-CHEK LINKASSIST | 11/27/2006 |
| K111467 | ELCAM MEDICAL A.C.A.L. | FLEXI-Q DV AND DVR AUTO-INJECTORS | 02/09/2012 |
| K213429 | Emed Technologies Corporation | AccuSert Needle Inserter | 10/20/2022 |
| K051667 | INDOLOR, LTD. | EZ-JECT | 09/27/2005 |
| K042557 | INNOJECT, INC | INNOJECT AUTO-INJECTOR | 11/08/2004 |
| K073476 | MEDICAL HOUSE (ASI) LIMITED | COMPACT AUTO-SAFETY INJECTOR (CASI) | 03/07/2008 |
| K082587 | MEDICAL HOUSE PRODUCTS LIMITED | AUTO-SAFETY INJECTOR-2 (ASI-2) | 10/02/2008 |
| K032848 | MEDSOLVE TECHNOLOGIES LLC | MEDSAFE SYSTEM INSERTER | 04/12/2004 |
| K160860 | MEDTRONIC MINIMED | MiniMed Quick-serter | 09/22/2016 |
| K970479 | MEDTRONIC MINIMED | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 | 03/31/1997 |
| K992300 | MEDTRONIC MINIMED | QUICK-SERTER, MODEL 395 | 07/29/1999 |
| K981266 | MIGHTY MO, CORP. | AUTO-INJECTOR, SURE-INJECT 2000 | 07/14/1998 |
| K010377 | MINIMED, INC. | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | 04/05/2001 |
| K013362 | OWEN MUMFORD USA, INC. | AUTOJECT 2 | 11/13/2001 |
| K993385 | Owen Mumford USA, Inc. | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | 11/10/1999 |
| K122837 | OWEN MUMFORD, LTD. | AUTOJECT 2 FOR GLASSY SYRINGE | 10/15/2012 |
| K000482 | OWEN MUMFORD, LTD. | MODIFICATION TO AUTOJECT MINI | 03/06/2000 |
| K060389 | PHARMA-PEN, INC. | CONFIDOSE IM AUTO-INJECTOR | 06/06/2006 |
| K961309 | POS-T-VAC, INC. | POS-T-VAC ID-300 | 06/10/1996 |
| K124026 | SCANDINAVIAN HEALTH LIMITED | LOBSTER AUTO-INJECTOR | 09/13/2013 |
| K141384 | SCANDINAVIAN HEALTH LIMITED | WHISPERJECT AUTOINJECTOR | 09/12/2014 |
| K954729 | SCANDINAVIAN HEALTH LTD. | PEN-INJECT 2.25 | 01/29/1996 |
| K060141 | SHL MEDICAL, USA | DAI-R | 06/12/2006 |
| K050434 | SHL MEDICAL, USA | SHL DISPOSABLE AUTOINJECTOR | 06/24/2005 |
| K974171 | TEVA MEDICAL, LTD. | COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS | 12/19/1997 |
| K033696 | UNION MEDICO APS | PERSONAL INJECTOR | 02/16/2005 |
| K163400 | YPSOMED AG | Orbit Inserter | 07/26/2017 |
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