Personal Injector
510(k) K033696
Personal Injector is a medical device (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, 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 | FDA 510(k)SESE | NumberK033696 | Date16 Feb 2005 | StatusActive |
Official records
- FDA 510(k) database K033696
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KZH
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6920
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K033696
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Needle Guide Assistant 1 | 1 | 05714472000004 | — | On the market |
Similar devices
Other devices filed under FDA product code KZH (Introducer, Syringe Needle).
- MiniMed Quick-serter by MEDTRONIC MINIMED, INC.
- AccuSert Needle Inserter by EMED Technologies Corporation
- FLEXI-Q DV AND DVR AUTO-INJECTORS by Elcam Medical ACAL
- MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 by Minimed, Inc.
- POS-T-VAC ID-300 by Pos-T-Vac LLC
- CONFIDOSE IM AUTO-INJECTOR by Pharma-Pen, Inc.
- ACCU-CHEK LINKASSIST by Disetronic Medical Systems
- MONOJECT INJECTOMATIC by Sherwood Medical Co.
- V-CATH BREAKAWAY NEEDLE INTRODUCER by Hdc Corp.
- GripMate by Synthon Hispania S.L.