PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border— 510(k) K192463

Substantially Equivalent

Winner Medical Co., Ltd.

FDA 510(k) clearance K192463 for PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB 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: 2019-09-09
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.