BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

    K Number: K160869 · Decision Apr 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    30

    Basic Information

    Device Name
    Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
    K Number
    K160869
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COOK BIOTECH INCORPORATED
    Date Received
    March 30, 2016
    Decision Date
    April 29, 2016
    Product Code
    FTM
    Advisory Committee
    General, Plastic Surgery
    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
    FTM Mesh, Surgical

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