Zetajet
FDA 510(k) K090003 · Bioject, Inc.
510(k) numberK090003
Submission
- Device name
- Zetajet
- Applicant
- Bioject, Inc.
Tualatin, OR, US - Received
- January 2, 2009
- Decision date
- April 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZE – Injector, Fluid, Non-Electrically Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5430
- Specialty
- General Hospital
Other 510(k)s with product code KZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121270 | Bioject Needle-Free Injection Management SystemKZE · Traditional | Bioject Medical Technologies, Inc. | 07/19/2012SE |
| K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special | Pharmajet, Inc. | 07/27/2011SE |
| K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 03/02/2011SE |
| K090959 | Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional | D'Antonio Consultants International, Inc. (Dci) | 12/24/2009SE |
| K081532 | Pharmajet Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 02/26/2009SE |
| K082138 | Airgent, Model AG7000010KZE · Traditional | Perfaction, Inc. | 01/23/2009SE |
| K060819 | Cool.Click 2KZE · Traditional | Medical House Products Limited | 06/16/2006SE |
| K051985 | Biovalve Mini-Ject Needlefree InjectorKZE · Special | Biovalve Technologies, Inc. | 08/17/2005SE |
| K050734 | Cool.ClickKZE · Traditional | Bioject, Inc. | 06/03/2005SE |
| K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000KZE · Traditional | Genesis Medical Technology, Inc. | 11/08/2004SE |
More from Genesis Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050734 | Cool.ClickKZE · Traditional | 06/03/2005SE |
| K010623 | Reconstitution Kit & Vial ConnectorLHI · Traditional | 04/05/2001SE |
| K003908 | SerojetKZE · Traditional | 03/08/2001SE |
| K994384 | ClickerKZE · Traditional | 06/22/2000SE |
| K960373 | Biojector 2000 Model 1B02000KZE · Traditional | 03/05/1997SE |
| K963012 | Bioject Needle-Free Vial Adapter (13MM)LHI · Traditional | 10/15/1996SE |
| K920631 | Bioject Jet Injection SystemKZE · Traditional | 06/28/1994SE |
| K861687 | Biojector Syringe SystemKZE · Traditional | 04/23/1987SE |
Questions and answers
When was Zetajet cleared by the FDA?
Zetajet (K090003) received a 510(k) decision of Substantially Equivalent on April 2, 2009, 90 days after the submission was received.
What is the product code of K090003?
The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.