# K231183: Non absorbable Surgical Polyester Suture

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Haidike Medical Products Co., Ltd.
- Decided: Aug 25, 2023 after 121 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K960327 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172149: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture,  FILAPROP - Non Absorbable Polypropylene surgical Suture, M/s. Meril Endo Surgery Private Limited. (2017) Summary page 4.

## Indications for use
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, 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/K231183
Methodology: https://510kreport.com/methodology