# K072863: Atramat PGC25 Poly (Glycolide-CO-Epsilon-Caprolactone) Surgical Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Internacional Farmaceutica, S.A. DE C.V.
- Decided: May 23, 2008 after 231 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 K960653 (1996). 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)
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 1.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.

## Indications for use
Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K072863
Methodology: https://510kreport.com/methodology