FDA.reportPublic FDA data

510(k) K260020

Device
Redermo Wound Matrix
Applicant
Beijing Kreate Medical Co., Ltd.
510(k) number
K260020
Product code
QSZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-16
Date received
2026-01-05
Classification name
Absorbable Synthetic Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Gary Gao
Address
C306, W. Ring S. Rd. #18, E-Town Beijing CN 100023 100023

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.2025-06-20
K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.2025-03-05
K241660SiOxD® Wound MatrixSioxmed, LLC2024-07-05
K232847SiOxD Wound MatrixSioxmed, LLC2023-12-18
K223725Restrata® MiniMatrixAcera Surgical, Inc.2023-05-18
K222189SiOxD Wound MatrixSioxmed, LLC2022-11-18
K221686NovoSorb MatrixPolynovo Biomaterials Pty, Ltd.2022-09-15
K193583Restrata®Acera Surgical, Inc.2020-09-25
K173544Phoenix Wound MatrixNanofiber Solutions, Inc.2018-03-02
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.2017-08-11
K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH2017-06-28
K170300Restrata Wound MatrixAcera Surgical, Inc.2017-04-26
K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC2016-09-15
K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.2015-12-23
K132397GORE BIO-A WOUND MATRIXW. L. Gore & Associates, Inc.2014-05-07