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510(k) Data Aggregation

    K Number
    K172538
    Device Name
    Disposable Linear Stapler, Disposable Linear Cutter
    Date Cleared
    2017-11-30

    (100 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: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. Disposable Linear Cutter: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
    Device Description
    Disposable Linear Stapler: The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in a variety of sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness. The model number defines the staple line. For example, the 30 mm instruments create a 30-mm staple line, the 45 mm instruments create a 45-mm staple line, the 60 mm instruments create a 60-mm staple line and 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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