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510(k) Data Aggregation

    K Number
    K210495
    Device Name
    Port Access System
    Date Cleared
    2021-06-18

    (116 days)

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

    Surgical Innovations Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
    Device Description
    The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition. In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.
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    K Number
    K190592
    Device Name
    YelloPort Elite Port Access System
    Date Cleared
    2019-04-29

    (53 days)

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

    Surgical Innovations Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum. The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.
    Device Description
    The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only. In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal Seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulas are available in a range of lengths and diameters.
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