# K073614: WG-Surgical Sutures with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Foosin Medical Supplies, Inc.
- Decided: Apr 30, 2008 after 126 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K014153 (2002). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging, Tyco Healthcare Group (2007) Summary page 2.
- K053380: Contour Thread Synthetic Absorbable Pdo Barbed Suture, Surgical Specialties Corp (2006) Summary page 2.

## Most influential descendants
- K200392: Rexsin (2020), 0 descendants of its own
- K173779: Rexmono, Pdrex (2018), 0 descendants of its own

## Indications for use
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues. Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

Source page: https://510kreport.com/device/K073614
Methodology: https://510kreport.com/methodology