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510(k) Data Aggregation

    K Number
    K052770
    Device Name
    PATHFORMER
    Manufacturer
    PATH SCIENTIFIC, LLC
    Date Cleared
    2005-10-31

    (31 days)

    Product Code
    NWF
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    NWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PathFormer device is intended for use in relieving pressure from subungual hematomas (including black toe). It cuts through finger and toe nails to release fluid accumulated in the underlying nail bed.
    Device Description
    The Path Scientific, LLC. PathFormer is a battery-powered hand-held drill that cuts holes in fingernails and toenails using mesoscissioning technology. It cuts the nail with a microcutting tool, using skin impedance as the feedback mechanism for stopping the cutting intervention.
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