KZH — Introducer, Syringe Needle Class II
FDA product code KZH covers "Introducer, Syringe Needle", a Class II medical device regulated under 21 CFR 880.6920. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KZH
- Device Class
- Class II
- Regulation Number
- 880.6920
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243232 | Synthon Hispania S.L | GripMate | Dec 2, 2024 |
| K213429 | Emed Technologies Corporation | AccuSert Needle Inserter | Oct 20, 2022 |
| K163400 | Ypsomed | Orbit Inserter | Jul 26, 2017 |
| K160860 | Medtronic Minimed | MiniMed Quick-serter | Sep 22, 2016 |
| K141384 | Scandinavian Health Limited | WHISPERJECT AUTOINJECTOR | Sep 12, 2014 |
| K124026 | Scandinavian Health Limited | LOBSTER AUTO-INJECTOR | Sep 13, 2013 |
| K122837 | Owen Mumford | AUTOJECT 2 FOR GLASSY SYRINGE | Oct 15, 2012 |
| K111467 | Elcam Medical Acal | FLEXI-Q DV AND DVR AUTO-INJECTORS | Feb 9, 2012 |
| K082587 | Medical House Products Limited | AUTO-SAFETY INJECTOR-2 (ASI-2) | Oct 2, 2008 |
| K073476 | Medical House (Asi) Limited | COMPACT AUTO-SAFETY INJECTOR (CASI) | Mar 7, 2008 |
| K062339 | Dermoequipos | DERMOTHERAP GUN | Feb 5, 2007 |
| K063146 | Disetronic Medical Systems | ACCU-CHEK LINKASSIST | Nov 27, 2006 |
| K060141 | Shl Medical, Usa | DAI-R | Jun 12, 2006 |
| K060389 | Pharma-Pen | CONFIDOSE IM AUTO-INJECTOR | Jun 6, 2006 |
| K051667 | Indolor | EZ-JECT | Sep 27, 2005 |
| K050434 | Shl Medical, Usa | SHL DISPOSABLE AUTOINJECTOR | Jun 24, 2005 |
| K033696 | Union Medico Aps | PERSONAL INJECTOR | Feb 16, 2005 |
| K042557 | Innoject | INNOJECT AUTO-INJECTOR | Nov 8, 2004 |
| K032848 | Medsolve Technologies | MEDSAFE SYSTEM INSERTER | Apr 12, 2004 |
| K032425 | Biogen | INVISIJECT RESUSABLE AUTO-INJECTOR | Nov 5, 2003 |