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510(k) Data Aggregation

    K Number
    K100442
    Device Name
    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
    Date Cleared
    2010-09-07

    (202 days)

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

    SURGICAL INNOVATIONS GROUP PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
    Device Description
    The FastClamp Endoscopic Clamping System is a non sterile, reusable, laparoscopic clamp instrument. It comprises a table clamp to securely attach to the operating table accessory rail, and an instrument clamp to lock the instrument in place once the instrument has been positioned.
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    K Number
    K070712
    Device Name
    MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
    Date Cleared
    2007-03-28

    (14 days)

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

    SURGICAL INNOVATIONS GROUP PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum. The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
    Device Description
    The device comprises a trocar, available with a range of tips styles, and a base. The base forms the cannula and has a removable 'cap' which retains the valve and/or lip seal. The trocar and cannula elements of the device are fully reusable and can be sterilised in pressurised steam. Valves and seals are essential accessories used in conjunction with the cannula and are available in a range of formats depending on the specific market requirements. YelloPort is ergonomically designed to be strong and durable yet lightweight and easy to handle. Medical grade polymers ensure the main elements are fully reusable and can be autoclaved in pressurised steam. Cannulae are available with a choice of internal diameters and a range of working lengths. Trocars are made from the finest surgical steels, hand finished to give reliable and lasting performance. The patented shielded trocar is also fully reusable and can be taken apart for ease of cleaning and maintenance. The precision ground and polished cutting tubes can be replaced economically if they become blunt or damaged. The combination of reusable cannulae and trocars together with single-use valves / seals makes YelloPort a highly cost effective solution. The device is manufactured from materials that comply with the requirements of ISO 10993 in terms of biocompatibility. The YelloPort valves and seals are sterilised using a validated method of gamma irradiation, thereby providing a sterility assurance level of 106. The YelloPort cannulae bodies and trocars are provided non-sterile. Sterilisation instructions are provided in the instructions for use. The Surgical Innovations steam sterilisation and cleaning validation methods are based on the AAMI TIR No 12-1994, Designing, Testing and Labelling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufactures and proves a sterility assurance level of 106. Sterilisation validation of the steam sterilisations is based on three sterilisation cycles at one half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilised indicator.
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