FDA.reportPublic FDA data

510(k) K251567

Device
NovoSorb BTM
Applicant
Polynovo Biomaterials Pty, Ltd.
510(k) number
K251567
Product code
QSZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2025-05-22
Classification name
Absorbable Synthetic Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Shruti Dave
Address
2/320 Lorimer St. Port Melbourne Melbourne AU 3207 3207

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
K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.2026-04-16
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