# K982853: Silk Suture

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Apr 30, 1999 after 260 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 K930590 (1993). 1 ancestor in all.
16 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930590: Silk Sutures, Davis & Geck, Inc. (1993) Summary page 2.

## Most influential descendants
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), 15 descendants of its own
- K153307: HS SutureTape (2016), 7 descendants of its own
- K190817: HS Fiber (2019), 6 descendants of its own
- K231163: HS Fiber Sutures (2024), 3 descendants of its own
- K253910: Stitch - Suture Wires and Tapes (2026), 0 descendants of its own

## Indications for use
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

Source page: https://510kreport.com/device/K982853
Methodology: https://510kreport.com/methodology