Autoject 2
FDA 510(k) K945660 · Owen Mumford USA, Inc.
510(k) numberK945660
Submission
- Device name
- Autoject 2
- Applicant
- Owen Mumford USA, Inc.
Marietta, GA, US - Received
- November 17, 1994
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZH – Introducer, Syringe Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6920
- Specialty
- General Hospital
Other 510(k)s with product code KZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243232 | GripMateKZH · Traditional | Synthon Hispania S.L. | 12/02/2024SE |
| K213429 | AccuSert Needle InserterKZH · Traditional | Emed Technologies Corporation | 10/20/2022SE |
| K163400 | Orbit InserterKZH · Traditional | Ypsomed AG | 07/26/2017SE |
| K160860 | MiniMed Quick-serterKZH · Traditional | Medtronic Minimed | 09/22/2016SE |
| K141384 | Whisperject AutoinjectorKZH · Abbreviated | Scandinavian Health Limited | 09/12/2014SE |
| K124026 | Lobster Auto-InjectorKZH · Traditional | Scandinavian Health Limited | 09/13/2013SE |
| K122837 | Autoject 2 for Glassy SyringeKZH · Special | Owen Mumford, Ltd. | 10/15/2012SE |
| K111467 | Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional | Elcam Medical Acal | 02/09/2012SE |
| K082587 | Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional | Medical House Products Limited | 10/02/2008SE |
| K073476 | Compact Auto-Safety Injector (Casi)KZH · Traditional | Medical House (Asi) Limited | 03/07/2008SE |
More from Medical House (Asi) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K013362 | Autoject 2KZH · Traditional | 11/13/2001SE |
| K993385 | Autojet 2 (Non-Fixed Needle Type)KZH · Traditional | 11/10/1999SE |
| K983994 | UnifineFMF · Traditional | 01/08/1999SE |
| K983974 | Owen Mumford 3ML AutopenFMF · Traditional | 12/21/1998SE |
| K982275 | Rapport V.T.D.LKY · Traditional | 12/04/1998SE |
| K983045 | AmielleKXP · Traditional | 11/25/1998SE |
| K973899 | Unifine PentipsFMI · Traditional | 12/04/1997SE |
| K971443 | Rapport V.T.D.LKY · Traditional | 09/26/1997SE |
| K953735 | Autoject MiniKZH · Traditional | 11/08/1995SE |
Questions and answers
When was Autoject 2 cleared by the FDA?
Autoject 2 (K945660) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 267 days after the submission was received.
What is the product code of K945660?
The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.