# K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: May 11, 1998 after 55 days
- Product code: GAB (Needle, Suturing, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K932591 (1993). 1 ancestor in all.
4 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)
- K932591: Endo-Judge, Synergistic Medical Technologies, Inc. (1993) Summary page 1.

## Most influential descendants
- K983108: Suture Welding System and Kit (SWK) (1998), 3 descendants of its own
- 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 ASLS is indicated for the placement of synthetic monofilament sutures in soft tissues and for the ligation of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The ASLS is indicated for use in both traditional open surgery and endoscopic surgical procedures.

Source page: https://510kreport.com/device/K980988
Methodology: https://510kreport.com/methodology