# K241486: Sofsilk™ Coated Braided Silk Suture

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Dec 3, 2024 after 193 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- 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 K964581 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980124: Sofsilk Suture, United States Surgical, A Division of Tyco Healthc (1998) Summary page 5.

## Indications for use
Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K241486
Methodology: https://510kreport.com/methodology