# K230746: Non absorbable Surgical Polypropylene Suture

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Haidike Medical Products Co., Ltd.
- Decided: Sep 14, 2023 after 181 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K930586 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080684: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 4.

## Indications for use
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

Source page: https://510kreport.com/device/K230746
Methodology: https://510kreport.com/methodology