NovoSorb BTM
K-Number: K251567 · 2025-06-20
ApplicantPolynovo Biomaterials Pty, Ltd.
Decision Date2025-06-20
Product CodeQSZ
DecisionSubstantially Equivalent
Device Summary
NovoSorb BTM is a medical device manufactured by Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K251567. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovoSorb BTM?
NovoSorb BTM is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K251567.
When was NovoSorb BTM approved by the FDA?
NovoSorb BTM received FDA 510(k) clearance on 2025-06-20, under approval number K251567.
What company makes NovoSorb BTM?
NovoSorb BTM is manufactured by Polynovo Biomaterials Pty, Ltd..
What is the FDA product code for NovoSorb BTM?
The FDA product code for NovoSorb BTM is QSZ.
Other Devices by Polynovo Biomaterials Pty, Ltd.
Related Devices (Code: QSZ)
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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.