# K022664: Pga (Polyglycolic) Synthetic Absorbable Suture U.S.P.

- Pathway: 510(k) (Traditional)
- Applicant: Arc Medical Supplies (Beijing) Co, Ltd.
- Decided: Sep 10, 2002 after 32 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SURGISORB absorbable surgical sutures manufactured by SAMYANG Corporation: named in the summary without a submission number

## Indications for use
PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Source page: https://510kreport.com/device/K022664
Methodology: https://510kreport.com/methodology