# K130735: 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: 2 generations back to K980704 (1998). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122734: Aesculap Novosyn Absorbable Suture, Aesculap, Inc. (2012) Summary page 2.

## Most influential descendants
- K180027: ACCUSYTE 3D Fiducial Marker (2018), 0 descendants of its own
- K173043: Holycon Synthetic Absorbable Sutures (2017), 0 descendants of its own
- K161629: Crylrex (2017), 0 descendants of its own

## Indications for use
The WEGO-POLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K130735
Methodology: https://510kreport.com/methodology