# K130737: Synthetic Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Foosin Medical Supplies Inc., Ltd.
- Decided: Jan 14, 2014 after 302 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: 4 generations back to K960653 (1996). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut, Riverpoint Medical (2010) Summary page 2.

## Most influential descendants
- K142810: WEGO-PGCL Absorbable Surgical Monofilament Suture (2014), 1 descendant of its own
- K173779: Rexmono, Pdrex (2018), 0 descendants of its own

## Indications for use
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/ar ligation, but not for use in cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K130737
Methodology: https://510kreport.com/methodology