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 | December 2, 2024 |
| K213429 | emed technologies corporation | AccuSert Needle Inserter | October 20, 2022 |
| K163400 | ypsomed | Orbit Inserter | July 26, 2017 |
| K160860 | medtronic minimed | MiniMed Quick-serter | September 22, 2016 |
| K141384 | scandinavian health limited | WHISPERJECT AUTOINJECTOR | September 12, 2014 |
| K124026 | scandinavian health limited | LOBSTER AUTO-INJECTOR | September 13, 2013 |
| K122837 | owen mumford | AUTOJECT 2 FOR GLASSY SYRINGE | October 15, 2012 |
| K111467 | elcam medical acal | FLEXI-Q DV AND DVR AUTO-INJECTORS | February 9, 2012 |
| K082587 | medical house products limited | AUTO-SAFETY INJECTOR-2 (ASI-2) | October 2, 2008 |
| K073476 | medical house (asi) limited | COMPACT AUTO-SAFETY INJECTOR (CASI) | March 7, 2008 |
| K062339 | dermoequipos | DERMOTHERAP GUN | February 5, 2007 |
| K063146 | disetronic medical systems | ACCU-CHEK LINKASSIST | November 27, 2006 |
| K060141 | shl medical, usa | DAI-R | June 12, 2006 |
| K060389 | pharma-pen | CONFIDOSE IM AUTO-INJECTOR | June 6, 2006 |
| K051667 | indolor | EZ-JECT | September 27, 2005 |
| K050434 | shl medical, usa | SHL DISPOSABLE AUTOINJECTOR | June 24, 2005 |
| K033696 | union medico aps | PERSONAL INJECTOR | February 16, 2005 |
| K042557 | innoject | INNOJECT AUTO-INJECTOR | November 8, 2004 |
| K032848 | medsolve technologies | MEDSAFE SYSTEM INSERTER | April 12, 2004 |
| K032425 | biogen | INVISIJECT RESUSABLE AUTO-INJECTOR | November 5, 2003 |