BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇭 Switzerland

    Geistlich Wound Matrix PLUS

    K Number: K213607 · Decision Apr 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    27
    Review Days
    164

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    Basic Information

    Device Name
    Geistlich Wound Matrix PLUS
    K Number
    K213607
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geistlich Pharma AG
    Date Received
    November 15, 2021
    Decision Date
    April 28, 2022
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Geistlich Pharma AG

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    K251556 Device 300423 Granules
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    K250833 SwissMembrane X; SwissMembrane X Socket
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