# K002190: Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Aug 10, 2000 after 21 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072229: Monoswift (2007), 0 descendants of its own

## Recalls of this device
- Oct 18, 2019 · Class II · Z-0655-2020: Failed to meet USP minimum average value for knot pull (tensile) strength.
- Jan 2, 2009 · Not classified · Z-0260-2012: The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.

Source page: https://510kreport.com/device/K002190
Methodology: https://510kreport.com/methodology