BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇦🇺 Australia

    NovoSorb BTM

    K Number: K251567 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    NovoSorb BTM
    K Number
    K251567
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polynovo Biomaterials Pty, Ltd.
    Date Received
    May 22, 2025
    Decision Date
    June 20, 2025
    Product Code
    QSZ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSZ Absorbable Synthetic Wound Dressing

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    Other Clearances by Polynovo Biomaterials Pty, Ltd.

    K Number Device Name
    K242149 NovoSorb® MTX
    K221686 NovoSorb Matrix
    K172140 NovoSorb 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)
    K142879 BTM Wound Dressing
    K132936 NOVOPORE DRESSING