SYNTHETIC ABSORBABLE SUTURE— 510(k) K130735

Substantially Equivalent

Foosin Medical Supplies Inc., Ltd.

FDA 510(k) clearance K130735 for SYNTHETIC ABSORBABLE SUTURE, Substantially Equivalent on 2014-01-14. Applicant: Foosin Medical Supplies Inc., Ltd..

Clearance details

Applicant: Foosin Medical Supplies Inc., Ltd.
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2013-03-18
Decision date: 2014-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.