Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Redermo Wound Matrix

K-Number: K260020 · 2026-04-16

ApplicantBeijing Kreate Medical Co., Ltd.
Decision Date2026-04-16
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

Redermo Wound Matrix is a medical device manufactured by Beijing Kreate Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under approval number K260020. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Redermo Wound Matrix?

Redermo Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Beijing Kreate Medical Co., Ltd.. The 510(k) number is K260020.

When was Redermo Wound Matrix approved by the FDA?

Redermo Wound Matrix received FDA 510(k) clearance on 2026-04-16, under approval number K260020.

What company makes Redermo Wound Matrix?

Redermo Wound Matrix is manufactured by Beijing Kreate Medical Co., Ltd..

What is the FDA product code for Redermo Wound Matrix?

The FDA product code for Redermo Wound Matrix is QSZ.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Beijing Kreate Medical Co., Ltd.

K251582Redermax Antibacterial Wound Matrix

Related Devices (Code: QSZ)

K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd. K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH K170300Restrata Wound MatrixAcera Surgical, Inc. K173544Phoenix Wound MatrixNanofiber Solutions, Inc. K193583Restrata®Acera Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑