BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Foundation Dermal Regeneration Scaffold (DRS) Solo

    K Number: K231937 · Decision Nov 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    136

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    Basic Information

    Device Name
    Foundation Dermal Regeneration Scaffold (DRS) Solo
    K Number
    K231937
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionova Medical, Inc.
    Date Received
    June 30, 2023
    Decision Date
    November 13, 2023
    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 Bionova Medical, Inc.

    K Number Device Name
    K243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
    K240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
    K210949 Foundation Dermal Regeneration Scaffold (DRS) Solo
    K123961 SENTREX BIOSPONGE MPD
    K112191 HEALEX BIOSPONGE WOUND DRESSING