Ag Foam Dressing Non-Adhesive (OTC) +3 more— 510(k) K221754

Name: FDA 510(k) clearance K221754
Creator: U.S. Food and Drug Administration
Published: 2023-01-17

Substantially Equivalent

Winner Medical Co., Ltd.

FDA 510(k) clearance K221754 for Ag Foam Dressing Non-Adhesive (OTC) +3 more, Substantially Equivalent on 2023-01-17. Applicant: Winner Medical Co., Ltd.. Device class: Unclassified.

Clearance details

Device name as filed: Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
Applicant: Winner Medical Co., Ltd.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-06-16
Decision date: 2023-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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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.