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510(k) Data Aggregation

    K Number
    K210909
    Device Name
    easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
    Date Cleared
    2021-06-24

    (87 days)

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

    Ezisurg Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
    Device Description
    The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.
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    K Number
    K183477
    Device Name
    easyPPHTM Hemorrhoidal Stapler for Single Use
    Date Cleared
    2019-02-11

    (56 days)

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

    Ezisurg Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.
    Device Description
    The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.
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    K Number
    K181657
    Device Name
    easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
    Date Cleared
    2019-02-01

    (224 days)

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

    Ezisurg Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses. The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.
    Device Description
    The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure. The easyCS™ Circular Stapler for Single Use places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.
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    K Number
    K172960
    Device Name
    easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
    Date Cleared
    2017-12-21

    (86 days)

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

    Ezisurg Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The devices are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
    Device Description
    The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of easyEndoTM Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
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