# K041512: Nonabsorbable (Polyethylene Terephthalate) Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Private Limited
- Decided: Jun 2, 2005 after 360 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
Longest line of descent: 1 generation back to K961925 (1996). 1 ancestor in all.
3 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)
- K961925: Polyester Nonabsorbable Surgical Sutures Usp, R. K. Medical L. L. C. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K001172: Polyester Nonabsorbable Surgical Sutures Urp, Cp Medical (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
TRUBOND Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K041512
Methodology: https://510kreport.com/methodology