# K042314: Syringe Grip for the Avonex Pre-Filled Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Biogen
- Decided: Nov 22, 2004 after 88 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K860284 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032425: Invisiject Resusable Auto-Injector, Biogen (2003) Summary page 1.
- K820164: Empty Sterile Carpuject, Sterling Drug, Inc. (1982) Summary page 1.

## Indications for use
The Syringe Grip for the AVONEX prefilled syringe is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONEX from a prefilled syringe through a single lumen hypodermic needle. The devices are intended to be used in any setting including the home.

Source page: https://510kreport.com/device/K042314
Methodology: https://510kreport.com/methodology