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

    XenMatrix AB Surgical Graft

    K Number: K162193 · Decision Dec 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    141

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    Basic Information

    Device Name
    XenMatrix AB Surgical Graft
    K Number
    K162193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C. R. Bard
    Date Received
    August 4, 2016
    Decision Date
    December 23, 2016
    Product Code
    PIJ
    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
    PIJ Collagen Surgical Mesh Containing Drugs

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PIJ), ordered by most recent decision date.

    XenMatrix AB Surgical Graft

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    XENMATRIX AB SURGICAL GRAFT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

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