# K052482: Artelon Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: Artimplant AB
- Decided: Oct 17, 2005 after 38 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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 K930586 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032160: Artelon Surgical Suture, Artimplant AB (2003) Summary page 1.

## Indications for use
Artelon® Surgical Suture is intended for use in general soft tissue approximation and/or ligation during surgery.

Source page: https://510kreport.com/device/K052482
Methodology: https://510kreport.com/methodology