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510(k) Data Aggregation

    K Number
    K231042
    Device Name
    Disposable Laparoscopic Trocar
    Date Cleared
    2023-06-08

    (57 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Ankang Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
    Device Description
    The proposed devices are available in two types, bladeless type and bladed type, which consist of puncture needle, puncture sleeve, injection valve and sealing cover. In order to obtain access to the surgical site during laparoscopic surgery, the puncture needle is introduced into puncture sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the injection valve at its proximal end and once the abdominal/thoracic wall is puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. The bladeless type disposable laparoscopic trocar is available in 5mm, 10mm, 12mm four diameters, and the bladed type disposable laparoscopic trocar is available in 5mm, 10mm and 12mm three diameters to accommodate different sizes surgical instrument.
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