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

    TIGERPAW SYSTEM

    K Number: K101961 · Decision Oct 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    279
    Applicant Total
    2
    Review Days
    109

    Basic Information

    Device Name
    TIGERPAW SYSTEM
    K Number
    K101961
    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
    LAAX, INC.
    Date Received
    July 12, 2010
    Decision Date
    October 29, 2010
    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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    Other Clearances by LAAX, INC.

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    K111064 TIGERPAW SYSTEM II