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510(k) Data Aggregation

    K Number
    K133375
    Device Name
    BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
    Date Cleared
    2014-01-17

    (74 days)

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

    BANYAN MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
    Device Description
    The Banyan Medical line of Disposable Secondary Cannula and Trocars for Laparoscopic Use consists of a trocar, cannula sleeve and a silicone seal. The design has two possible trocars, a sharp faceted tip and a conical tip. An insufflation adapter, when supplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The Cannula and Trocar will be sold in 5mm, 8mm, 10mm and 12mm sizes.
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