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510(k) Data Aggregation

    K Number
    K142548
    Device Name
    MIDSLEEVE
    Date Cleared
    2015-06-23

    (286 days)

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

    MEDICAL INNOVATION DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
    Device Description
    MIDSLEEVE™ Calibration tube for Sleeve Gastrectomy is a sterile, single use medical device which consists of a 900 mm long, silicone tube of 37.5 French diameter, with a PVC valve at the proximal end of the tube. The tube has several holes and a rounded end, distal from the valve and an asymmetric balloon which can be filled through the valve. Reference markings are provided on the tube, from the distal end to 70 cm to locate the tube position.
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