Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border— 510(k) K191819

Substantially Equivalent

Winner Medical Co., Ltd.

FDA 510(k) clearance K191819 for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border, Substantially Equivalent on 2020-05-14. Applicant: Winner Medical Co., Ltd..

Clearance details

Applicant: Winner Medical Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2019-07-05
Decision date: 2020-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.