# K980124: Sofsilk Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 27, 1998 after 72 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: 1 generation back to K964581 (1997). 1 ancestor in all.
4 later devices descend from it; 2 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)
- K964581: Sofsilk, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.

## Most influential descendants
- K202950: StitchKit COMBO (2021), 2 descendants of its own
- K211792: StitchKit (2021), 1 descendant of its own
- K241486: Sofsilk™ Coated Braided Silk Suture (2024), 0 descendants of its own
- K221527: StitchKit (2023), 0 descendants of its own

## Indications for use
Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.

Source page: https://510kreport.com/device/K980124
Methodology: https://510kreport.com/methodology