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510(k) Data Aggregation

    K Number
    K193325
    Device Name
    Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
    Date Cleared
    2020-03-13

    (102 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ProSys International Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Avantgarde Faecal Management System (FMS) is intended for faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults.
    Device Description
    The Avantgarde Faecal Management System (catheter) is an invasive medical device to be used inside the body. It consists of a silicone catheter tube with inflation cuff and irrigation port, a 1,500ml collection bag, mounting plate with an attachment strap and 45ml syringe. This tray of devices, is supplied as a Convenience Kit. In addition, other related medical devices to enable the Avantgarde work effectively, include the Avantgarde Faecal Management System Replacement Pouches which are to be supplied on a bundle basis. This non-sterile device is for single use only. The FMS catheter tube is constructed of a silicone material. The balloon once inflated retains the device in the rectum. The liquid or semi-liquid stool is diverted into the drainage tube, which provides a route for the liquid or semi-liquid faecal matter to pass into the collection bag. Along the tube are two lumens with individual access ports. One port to inflate and deflate the balloon and the other to add water to flush and irrigate the catheter tube. Its shelf life is 5 years from the date of production.
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