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510(k) Data Aggregation

    K Number
    K130738
    Device Name
    ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
    Date Cleared
    2013-12-13

    (270 days)

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

    NANJING MAIDIXIN MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
    Device Description
    The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures. It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure. The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
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