# K970416: Acufex Double Armed Suture Needle

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Apr 21, 1997 after 76 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K961853 (1996). 2 ancestors 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)
- K961853: Proline Fast Pass Arthoscopic Needle Passer, Acufex Microsurgical, Inc. (1996) Summary page 1.

## Indications for use
The Acufex Double Armed Suture Needle is indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs.

Source page: https://510kreport.com/device/K970416
Methodology: https://510kreport.com/methodology