High Strength Suture— 510(k) K192637

Substantially Equivalent

Yunyi (Beijing) Medical Device Co., Ltd.

FDA 510(k) clearance K192637 for High Strength Suture, Substantially Equivalent on 2020-03-02. Applicant: Yunyi (Beijing) Medical Device Co., Ltd..

Clearance details

Applicant: Yunyi (Beijing) Medical Device Co., Ltd.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2019-09-24
Decision date: 2020-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.