KZE — Injector, Fluid, Non-Electrically Powered Class II
FDA product code KZE covers "Injector, Fluid, Non-Electrically Powered", a Class II medical device regulated under 21 CFR 880.5430. 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
- KZE
- Device Class
- Class II
- Regulation Number
- 880.5430
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121270 | bioject medical technologies | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | July 19, 2012 |
| K111517 | pharmajet | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJE | July 27, 2011 |
| K110456 | pharmajet | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | March 2, 2011 |
| K090959 | d'antonio consultants international, inc. (dci) | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | December 24, 2009 |
| K090003 | bioject | ZETAJET | April 2, 2009 |
| K081532 | pharmajet | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | February 26, 2009 |
| K082138 | perfaction | AIRGENT, MODEL AG7000010 | January 23, 2009 |
| K060819 | medical house products limited | COOL.CLICK 2 | June 16, 2006 |
| K051985 | biovalve technologies | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | August 17, 2005 |
| K050734 | bioject | COOL.CLICK | June 3, 2005 |
| K041239 | genesis medical technology | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | November 8, 2004 |
| K041280 | felton international | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | June 24, 2004 |
| K032976 | biovalve technologies | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | April 16, 2004 |
| K024018 | avant medical corporation | AVANT GUARDIAN 101 | January 17, 2003 |
| K020786 | rosch ag medizintechnic | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | September 25, 2002 |
| K022502 | equidyne systems | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | September 5, 2002 |
| K022148 | equidyne systems | INJEX 30 NEEDLE FREE INJECTION SYSTEM | July 23, 2002 |
| K013256 | felton international | BI-3M NEEDLE-FREE INJECTOR SYSTEM | December 7, 2001 |
| K003741 | equidyne systems | JET SYRINGE MODEL-100500 | June 1, 2001 |
| K003908 | bioject | SEROJET | March 8, 2001 |