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510(k) Data Aggregation

    K Number
    K150026
    Device Name
    Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
    Date Cleared
    2015-05-18

    (131 days)

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

    ETHICON ENDO-SURGERY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
    Device Description
    The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws. The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
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