Needle Guide Assistant 1
Needle Guide Assistant 1 is a subcutaneous self-injection aid (FDA Class II; FDA product code KZH, Introducer, Syringe Needle) made by Union Medico Aps, cleared under FDA 510(k) K033696 on 16 Feb 2005 and listed in FDA GUDID since 5 May 2025 (UDI-DI 05714472000004), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05714472000004 | Date5 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033696 | Date16 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 05714472000004
- FDA 510(k) database K033696
Across registries
- FDA 510(k) K033696 decided 16 Feb 2005 Active
- FDA GUDID UDI-DI 05714472000004 listed 5 May 2025 Listed
Timeline
- Cleared FDA 510(k) K033696
- Listed FDA GUDID 05714472000004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Needle Guide Assistant
- Generic name
- Subcutaneous self-injection aid
- Model / reference
- 1
- Primary DI / UDI-DI
- 05714472000004
- 510(k) Number
- FDA product code
- KZH
- GMDN term
- Subcutaneous self-injection aid
- Device class
- Class II
- Regulation number
- 880.6920
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KZH (Introducer, Syringe Needle).
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- AUTO-SAFETY INJECTOR-2 (ASI-2) by Medical House Products Limited
- The Injector by American Medical Innovations, Inc.
- Autoject Mini by OWEN MUMFORD USA, INC.
- EZ-JECT Introducer Syringe Needle by Indolor, Ltd.
- Pen-Inject 2.25 by Scandinavian Health Limited
- AUTO-INJECTOR, SURE-INJECT 2000 by Mighty Mo, Corp.
- MODIFICATION TO AUTOJECT MINI by Owen Mumford Ltd
- COMPACT AUTO-SAFETY INJECTOR (CASI) by Medical House (Asi) Limited