# K193209: Wego-Stainless Steel

- Pathway: 510(k) (Traditional)
- Applicant: Foosin Medical Supplies Inc., Ltd.
- Decided: Feb 19, 2020 after 90 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- 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 K946173 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170767: Surgical Stainless Steel Suture, Stainless Steel Suture, ETHICON, Inc. (2017) Summary page 5.

## Indications for use
The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Source page: https://510kreport.com/device/K193209
Methodology: https://510kreport.com/methodology