Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6920](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6920) → KZH — Introducer, Syringe Needle # KZH · Introducer, Syringe Needle _General Hospital · 21 CFR 880.6920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH ## Overview - **Product Code:** KZH - **Device Name:** Introducer, Syringe Needle - **Regulation:** [21 CFR 880.6920](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6920) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K243232.md) | GripMate | Synthon Hispania S.L. | Dec 2, 2024 | SESE | | [K213429](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K213429.md) | AccuSert Needle Inserter | Emed Technologies Corporation | Oct 20, 2022 | SESE | | [K163400](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K163400.md) | Orbit Inserter | Ypsomed AG | Jul 26, 2017 | SESE | | [K160860](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K160860.md) | MiniMed Quick-serter | Medtronic Minimed | Sep 22, 2016 | SESE | | [K141384](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K141384.md) | WHISPERJECT AUTOINJECTOR | Scandinavian Health Limited | Sep 12, 2014 | SESE | | [K124026](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K124026.md) | LOBSTER AUTO-INJECTOR | Scandinavian Health Limited | Sep 13, 2013 | SESE | | [K122837](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K122837.md) | AUTOJECT 2 FOR GLASSY SYRINGE | Owen Mumford, Ltd. | Oct 15, 2012 | SESE | | [K111467](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K111467.md) | FLEXI-Q DV AND DVR AUTO-INJECTORS | Elcam Medical Acal | Feb 9, 2012 | SESE | | [K082587](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K082587.md) | AUTO-SAFETY INJECTOR-2 (ASI-2) | Medical House Products Limited | Oct 2, 2008 | SESE | | [K073476](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K073476.md) | COMPACT AUTO-SAFETY INJECTOR (CASI) | Medical House (Asi) Limited | Mar 7, 2008 | SESE | | [K062339](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K062339.md) | DERMOTHERAP GUN | Dermoequipos S.R.L. | Feb 5, 2007 | SESE | | [K063146](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K063146.md) | ACCU-CHEK LINKASSIST | Disetronic Medical Systems AG | Nov 27, 2006 | SESE | | [K060141](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K060141.md) | DAI-R | Shl Medical, USA | Jun 12, 2006 | SESE | | [K060389](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K060389.md) | CONFIDOSE IM AUTO-INJECTOR | Pharma-Pen, Inc. | Jun 6, 2006 | SESE | | [K051667](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K051667.md) | EZ-JECT | Indolor, Ltd. | Sep 27, 2005 | SESE | | [K050434](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K050434.md) | SHL DISPOSABLE AUTOINJECTOR | Shl Medical, USA | Jun 24, 2005 | SESE | | [K033696](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K033696.md) | PERSONAL INJECTOR | Union Medico Aps | Feb 16, 2005 | SESE | | [K042557](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K042557.md) | INNOJECT AUTO-INJECTOR | Innoject, Inc. | Nov 8, 2004 | SESE | | [K032848](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K032848.md) | MEDSAFE SYSTEM INSERTER | Medsolve Technologies, LLC | Apr 12, 2004 | SESE | | [K032425](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH/K032425.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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