# K983108: Suture Welding System and Kit (SWK)

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Nov 27, 1998 after 84 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932591 (1993). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls), Axya Medical, Inc. (1998) Summary page 1.
- K932591: Endo-Judge, Synergistic Medical Technologies, Inc. (1993) Summary page 1.

## Most influential descendants
- K992405: Axya Medical Inc, Bone Anchor System and Kit- (Bak) (1999), 1 descendant of its own
- K070253: Axya Suture Welding System and Kit (2007), 0 descendants of its own
- K994313: Modification to Bone Anchor and Kit (Bak) (2000), 0 descendants of its own

## Indications for use
The Suture Welding System and Kit is indicated for securing synthetic monofilament sutures in soft tissues and for securing ligatures of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The SWK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

Source page: https://510kreport.com/device/K983108
Methodology: https://510kreport.com/methodology