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510(k) Data Aggregation

    K Number
    K034029
    Device Name
    TI CLIP APPLIER
    Manufacturer
    GYRX, LLC
    Date Cleared
    2004-03-05

    (67 days)

    Product Code
    NJC
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYRX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ti Clip Applier is indicated for ligation of the vas deferens.
    Device Description
    Ti Clip Applier
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    K Number
    K033161
    Device Name
    VISU-LOCK 5MM CLIP APPLIER
    Manufacturer
    GYRX, LLC
    Date Cleared
    2003-12-18

    (79 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYRX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Device Description
    Not Found
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