# K990432: Surgisorb

- Pathway: 510(k) (Traditional)
- Applicant: Sutures, Ltd.
- Decided: May 27, 1999 after 105 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 no predicate by number.

## Indications for use
Surgisorb is indicated for use in general tissue approximation and or ligation, including use in ophthalmic procedures but not for use in cardiac or neurological procedures.

Source page: https://510kreport.com/device/K990432
Methodology: https://510kreport.com/methodology