Collagen Wound Dressing— 510(k) K252001

Substantially Equivalent

Winner Medical Co., Ltd.

FDA 510(k) clearance K252001 for Collagen Wound Dressing, Substantially Equivalent on 2025-10-10. Applicant: Winner Medical Co., Ltd..

Clearance details

Applicant
Winner Medical Co., Ltd.
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code KGN

product code KGN
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.