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510(k) Data Aggregation

    K Number
    K152618
    Device Name
    PANTHER Cutter Stapler
    Date Cleared
    2015-11-12

    (59 days)

    Product Code
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
    Device Description
    The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
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