# K032160: Artelon Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Artimplant AB
- Decided: Nov 17, 2003 after 125 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: 2 generations back to K930586 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993998: NYLON, Trading Consultants and Distributors Intl., Inc. (2000) Summary page 1.
- K981582: Surgilon, Dermalon, & Ophthalon, Davis & Geck, Inc. (1998) Summary page 1.
- K003000: Grams Nylon Nonabsorbable Suture, Gramsmed, LLC (2000)
- K001173: Nylon, Nonabsorbable Surgical Sutures Usp, Cp Medical (2000)

## Most influential descendants
- K052482: Artelon Surgical Suture (2005), 0 descendants of its own

## Indications for use
The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K032160
Methodology: https://510kreport.com/methodology