# K041511: Trulene Non-Absorbable Polypropylene Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Private Limited
- Decided: Jun 3, 2005 after 361 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K961389 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961389: Polypropylene Nonabsorbable Surgical Sutures, R. K. Medical L. L. C. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K000185: Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM), W. L. Gore & Associates, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
TRULON TM Non-absorbable Polypropylene 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/K041511
Methodology: https://510kreport.com/methodology