# K253910: Stitch - Suture Wires and Tapes

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Aug 22, 2026 after 257 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: 8 generations back to K904436 (1990). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231163: HS Fiber Sutures, Riverpoint Medical (2024) Summary page 5.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 5.

## Indications for use
Stitch - Suture Wires and Tapes are indicated for use in general soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K253910
Methodology: https://510kreport.com/methodology