# K033409: Amersham Health Needle-Guard

- Pathway: 510(k) (Traditional)
- Applicant: Gettig Pharmaceutical Instrument Co.
- Decided: Jan 21, 2004 after 89 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000455 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000455: Gettig Guard, Gettig Pharmaceutical Instrument Co. (2000) Summary page 1.

## Indications for use
The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K033409
Methodology: https://510kreport.com/methodology