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

    Tri-Staple 2.0 Reinforced Reload

    K Number: K173270 · Decision Feb 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    130
    Review Days
    131

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    Basic Information

    Device Name
    Tri-Staple 2.0 Reinforced Reload
    K Number
    K173270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien
    Date Received
    October 12, 2017
    Decision Date
    February 20, 2018
    Product Code
    GDW
    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
    GDW Staple, Implantable

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