# K961925: Polyester Nonabsorbable Surgical Sutures Usp

- Pathway: 510(k) (Traditional)
- Applicant: R. K. Medical L. L. C.
- Decided: Jul 29, 1996 after 73 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Ti-cron polyester nonabsorbable surgical suture USP: named in the summary without a submission number

## Most influential descendants
- K041512: Nonabsorbable (Polyethylene Terephthalate) Surgical Suture (2005), 3 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
- K172149: 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 (2017), 1 descendant of its own
- K231183: Non absorbable Surgical Polyester Suture (2023), 0 descendants of its own

## Indications for use
The polyester nonabsorbable surgical 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/K961925
Methodology: https://510kreport.com/methodology