Redermo Wound Matrix

FDA 510(k) K260020 · Beijing Kreate Medical Co., Ltd.

Substantially Equivalent

510(k) numberK260020

Submission

Device name
Redermo Wound Matrix
Applicant
Beijing Kreate Medical Co., Ltd.
Beijing, CN
Received
January 5, 2026
Decision date
April 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QSZ – Absorbable Synthetic Wound Dressing
Device class
Unclassified

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Other 510(k)s with product code QSZ

510(k)DeviceApplicantDecision
K261311HyalomatrixQSZ · Traditional Anika Therapeutics, Inc.09/02/2026SE
K254256LUOFUCON® Wound MatrixQSZ · Traditional Huizhou Foryou Medical Devices Co., Ltd.08/18/2026SE
K251567NovoSorb BTMQSZ · Special Polynovo Biomaterials Pty, Ltd.06/20/2025SE
K242149NovoSorb® MTXQSZ · Traditional Polynovo Biomaterials Pty, Ltd.03/05/2025SE
K241660SiOxD® Wound MatrixQSZ · Special Sioxmed, LLC07/05/2024SE
K232847SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC12/18/2023SE
K223725Restrata® MiniMatrixQSZ · Traditional Acera Surgical, Inc.05/18/2023SE
K222189SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC11/18/2022SE
K221686NovoSorb MatrixQSZ · Special Polynovo Biomaterials Pty, Ltd.09/15/2022SE
K193583Restrata®QSZ · Special Acera Surgical, Inc.09/25/2020SE

More from Acera Surgical, Inc.

510(k)DeviceDecision
K261646Redermax® Antibacterial Wound MatrixFRO · Traditional 08/14/2026SE
K251582Redermax Antibacterial Wound MatrixFRO · Traditional 02/02/2026SE

Questions and answers

When was Redermo Wound Matrix cleared by the FDA?

Redermo Wound Matrix (K260020) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 101 days after the submission was received.

What is the product code of K260020?

The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.