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510(k) Data Aggregation

    K Number
    K172561
    Device Name
    Disposable Circular Stapler
    Date Cleared
    2017-12-05

    (102 days)

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

    Changzhou Kangdi Medical Stapler Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-to-side anastomoses.
    Device Description
    The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
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    K Number
    K121474
    Device Name
    DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
    Date Cleared
    2012-07-16

    (59 days)

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

    CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Linear Stapler, Model KYFB-30 / 60 / 90: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. Disposable Linear Cutter, Model KYQII-60 / 80 / 100: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
    Device Description
    General Disposable Linear Stapler: The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in three sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness .The 30 mm instruments create a 30 mm staple line, the 60 mm instruments create a 60 mm staple line, the 90 mm instruments create a 90 mm staple line. Disposable Linear Cutter: The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
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    K Number
    K100723
    Device Name
    DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
    Date Cleared
    2010-04-30

    (46 days)

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

    CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.
    Device Description
    The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.
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