Redermax® Antibacterial Wound Matrix— 510(k) K261646

Name: FDA 510(k) clearance K261646
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Beijing Kreate Medical Co., Ltd.

FDA 510(k) clearance K261646 for Redermax® Antibacterial Wound Matrix, Substantially Equivalent on 2026-08-14. Applicant: Beijing Kreate Medical Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Beijing Kreate Medical Co., Ltd.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-05-18
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

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K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24
K261638 — Bonvadis®2026-06-17
K254073 — StatSeal Disc2026-05-13

More clearances from Beijing Kreate Medical Co., Ltd.

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K260020 — Redermo Wound Matrix2026-04-16
K251582 — Redermax Antibacterial Wound Matrix2026-02-02

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.