BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PATHFORMER

    K Number: K052770 · Decision Oct 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    PATHFORMER
    K Number
    K052770
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Path Scientific, LLC
    Date Received
    September 30, 2005
    Decision Date
    October 31, 2005
    Product Code
    NWF
    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
    NWF Drill, Battery Powered, Subungual Hematoma