# K192637: High Strength Suture

- Pathway: 510(k) (Traditional)
- Applicant: Yunyi (Beijing) Medical Device Co., Ltd.
- Decided: Mar 2, 2020 after 160 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: 7 generations back to K990088 (1999). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190817: HS Fiber, Riverpoint Medical (2019) Summary page 5.

## Indications for use
The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures

Source page: https://510kreport.com/device/K192637
Methodology: https://510kreport.com/methodology