Redermo Wound Matrix— 510(k) K260020

Substantially Equivalent

Beijing Kreate Medical Co., Ltd.

FDA 510(k) clearance K260020 for Redermo Wound Matrix, Substantially Equivalent on 2026-04-16. Applicant: Beijing Kreate Medical Co., Ltd.. Device class: Unclassified.

Summary

Beijing Kreate Medical's Redermo Wound Matrix is filed under product code QSZ (Absorbable Synthetic Wound Dressing). The record doesn't describe the matrix beyond its name and that code name.

Class U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).

Beijing Kreate Medical filed from Beijing, China. The decision came 101 calendar days after FDA received it (January 5 to April 16, 2026).

Clearance details

Applicant
Beijing Kreate Medical Co., Ltd.
Product code
Product code QSZ
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beijing, CN
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.