# K960328: Silk Nonabsorbable Surgical Sutures Usp

- Pathway: 510(k) (Traditional)
- Applicant: R. K. Medical L. L. C.
- Decided: Mar 4, 1996 after 40 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Silk nonabsorbable surgical sutures manufactured by Davis + Geck: named in the summary without a submission number

## Most influential descendants
- K041514: Truesilk Non-Absorbable Silk Surgical Suture (2005), 13 descendants of its own
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K160623: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (2016), 2 descendants of its own
- K173747: Rexlene (2018), 1 descendant of its own

## Indications for use
The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K960328
Methodology: https://510kreport.com/methodology