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510(k) Data Aggregation

    K Number
    K980997
    Device Name
    PGK DEVICE (MODIFIED)
    Manufacturer
    PGK, INC.
    Date Cleared
    1998-09-28

    (195 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PGK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precise three-dimensional placement of needles into a sterile Field of the human body for diagnostic and therapeutic purposes, including brachytherapy for prostate cancer
    Device Description
    The modified PGK device includes a stereotactic bridge made of stainless steel and an aluminum protractor, which is attached to the bridge. The template in the modified PGK device, which substitutes the guidance device in the predicate PGK, is made of teflon. A post and bracket attachment to the template is made of stainless steel. The modified PGK is manufactured by Associated Design and Manufacturing (Registration #1122860) at 814 N. Henry St., Alexandria, Virginia.
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