WG-SURGICAL SUTURES WITH NEEDLE— 510(k) K080684

Substantially Equivalent

Foosin Medical Supplies, Inc.

FDA 510(k) clearance K080684 for WG-SURGICAL SUTURES WITH NEEDLE, Substantially Equivalent on 2008-06-09. Applicant: Foosin Medical Supplies, Inc..

Clearance details

Applicant: Foosin Medical Supplies, Inc.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2008-03-10
Decision date: 2008-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhong Shan, Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.