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

    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

    K Number: K181940 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    8
    Applicant Total
    163
    Review Days
    29

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    Basic Information

    Device Name
    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K Number
    K181940
    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
    W. L. Gore & Associates, Inc.
    Date Received
    July 19, 2018
    Decision Date
    August 17, 2018
    Product Code
    OXC
    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
    OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement

    Similar 510(k) Clearances

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

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    GORE SEAMGUARD Reinforcement

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

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