K261646
- 510(k) number
- K261646
- Device name
- Redermax® Antibacterial Wound Matrix
- Applicant
- Beijing Kreate Medical Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-08-14
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261646.pdf
Official FDA record: K261646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.