# K964581: Sofsilk

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jan 16, 1997 after 62 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K900840: Sofsilk*. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K902874: Sofsilk*. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K903509: Sofsilk*. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K980124: Sofsilk Suture (1998), 4 descendants of its own
- 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
Due to its nonabsorbable nature, SOF SILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.

Source page: https://510kreport.com/device/K964581
Methodology: https://510kreport.com/methodology