BEUDAMED
    Product Code: QSZ FDA unclassified

    Absorbable Synthetic Wound Dressing

    Unknown

    The Absorbable Synthetic Wound Dressing is a device intended to provide a physical barrier over a wound and maintain a moist wound healing environment, left in place following topical application and designed to be absorbed by the body over time without requiring removal. Its classification is currently unclassified (pending formal classification determination), reviewed under the General and Plastic Surgery panel. The absorbable nature of the material raises specific biocompatibility and safety questions that inform the classification process. It is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    19
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    10
    Years Active
    22

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    Basic Information

    Product Code
    QSZ
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

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

    Unclassified Reason

    1

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K260020 Redermo Wound Matrix
    K251567 NovoSorb BTM
    K242149 NovoSorb® MTX
    K241660 SiOxD® Wound Matrix
    K232847 SiOxD Wound Matrix
    K223725 Restrata® MiniMatrix
    K222189 SiOxD Wound Matrix
    K221686 NovoSorb Matrix
    K193583 Restrata®
    K173544 Phoenix Wound 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)
    K170213 SupraSDRM Biodegradable Matrix Wound Dressing
    K170300 Restrata Wound Matrix
    K161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
    K142879 BTM Wound Dressing
    K132397 GORE BIO-A WOUND MATRIX
    K090160 SUPRATHEL WOUND AND BURN DRESSING
    K073251 HYALOMATRIX PA
    K031684 TOPKIN WOUND DRESSING

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.