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510(k) Data Aggregation

    K Number
    K133345
    Device Name
    REVEEL ENDOSCOPIC RETRACTOR
    Manufacturer
    RETRACTION LIMITED
    Date Cleared
    2014-04-11

    (163 days)

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

    RETRACTION LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    REVEEL is designed as an organ and tissue retractor for the use in endoscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites.
    Device Description
    REVEEL is a single use device intended for mobilizing and maneuvering organs and tissue during endoscopic surgical procedures. It is comprised of a proximal handle, a rigid shaft, and a distal retraction surface.
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