# K141625: Polysyn Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: Surgical Specialties Corp
- Decided: Jul 18, 2014 after 31 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 K965162 (1997). 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)
- K965162: Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated, Braided-U.S.P., Lukens Medical Corp. (1997) Summary page 1.

## Indications for use
POLYSYNTM Polyglycolic Acid (PGA) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures.

Source page: https://510kreport.com/device/K141625
Methodology: https://510kreport.com/methodology