KZH · Introducer, Syringe Needle
General Hospital · 21 CFR 880.6920 · Class 2
Overview
| Product Code | KZH |
|---|---|
| Device Name | Introducer, Syringe Needle |
| Regulation | 21 CFR 880.6920 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243232 | GripMate | Synthon Hispania S.L. | Dec 2, 2024 | SESE |
| K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | Oct 20, 2022 | SESE |
| K163400 | Orbit Inserter | Ypsomed AG | Jul 26, 2017 | SESE |
| K160860 | MiniMed Quick-serter | Medtronic Minimed | Sep 22, 2016 | SESE |
| K141384 | WHISPERJECT AUTOINJECTOR | Scandinavian Health Limited | Sep 12, 2014 | SESE |
| K124026 | LOBSTER AUTO-INJECTOR | Scandinavian Health Limited | Sep 13, 2013 | SESE |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | Owen Mumford, Ltd. | Oct 15, 2012 | SESE |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | Elcam Medical Acal | Feb 9, 2012 | SESE |
| K082587 | AUTO-SAFETY INJECTOR-2 (ASI-2) | Medical House Products Limited | Oct 2, 2008 | SESE |
| K073476 | COMPACT AUTO-SAFETY INJECTOR (CASI) | Medical House (Asi) Limited | Mar 7, 2008 | SESE |
| K062339 | DERMOTHERAP GUN | Dermoequipos S.R.L. | Feb 5, 2007 | SESE |
| K063146 | ACCU-CHEK LINKASSIST | Disetronic Medical Systems AG | Nov 27, 2006 | SESE |
| K060141 | DAI-R | Shl Medical, USA | Jun 12, 2006 | SESE |
| K060389 | CONFIDOSE IM AUTO-INJECTOR | Pharma-Pen, Inc. | Jun 6, 2006 | SESE |
| K051667 | EZ-JECT | Indolor, Ltd. | Sep 27, 2005 | SESE |
| K050434 | SHL DISPOSABLE AUTOINJECTOR | Shl Medical, USA | Jun 24, 2005 | SESE |
| K033696 | PERSONAL INJECTOR | Union Medico Aps | Feb 16, 2005 | SESE |
| K042557 | INNOJECT AUTO-INJECTOR | Innoject, Inc. | Nov 8, 2004 | SESE |
| K032848 | MEDSAFE SYSTEM INSERTER | Medsolve Technologies, LLC | Apr 12, 2004 | SESE |
| K032425 | INVISIJECT RESUSABLE AUTO-INJECTOR | Biogen | Nov 5, 2003 | SESE |
Top Applicants
- Owen Mumford USA, Inc. — 4 clearances
- Medtronic Minimed — 3 clearances
- Hdc Corp. — 2 clearances
- Owen Mumford, Ltd. — 2 clearances
- Pavel Jordan & Associates, Inc. — 2 clearances
