# K043539: Demetech Sterile Synthetic Absorbable Sutures (Pga) and Needles

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: Apr 6, 2005 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
Longest line of descent: 1 generation back to K984374 (1999). 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)
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 1.

## Indications for use
The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

Source page: https://510kreport.com/device/K043539
Methodology: https://510kreport.com/methodology