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510(k) Data Aggregation

    K Number
    K190512
    Device Name
    SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
    Manufacturer
    Intelligent Endoscopy
    Date Cleared
    2019-11-22

    (266 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intelligent Endoscopy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper G1 tract.
    Device Description
    The SmartBand® EMR Device is an endoscopic mucosal resection device that is provided as a Kit or a Pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand® EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare™ EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube, and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand® EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord, which can be used when more bands are needed to complete the procedure.
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