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510(k) Data Aggregation

    K Number
    K150068
    Device Name
    Unimicro Veress Needle
    Manufacturer
    Unimicro Medical Systems (ShenZhen) Co.,Ltd.
    Date Cleared
    2015-07-31

    (199 days)

    Product Code
    HIF, FHO
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Unimicro Medical Systems (ShenZhen) Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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