# K041515: Truglyde Absorbable Polyglycolic Acid Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Private Limited
- Decided: Apr 8, 2005 after 305 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K990951 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990951: Maxon** Sterile, Synthetic, Absorbable Suture, United States Surgical, A Division of Tyco Healthc (1999) Summary page 4.
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 4.

## Indications for use
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures

Source page: https://510kreport.com/device/K041515
Methodology: https://510kreport.com/methodology