# K070253: Axya Suture Welding System and Kit

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Jul 11, 2007 after 166 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: 3 generations back to K932591 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983108: Suture Welding System and Kit (SWK), Axya Medical, Inc. (1998) Summary page 1.

## Indications for use
The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.

Source page: https://510kreport.com/device/K070253
Methodology: https://510kreport.com/methodology