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510(k) Data Aggregation

    K Number
    K120796
    Device Name
    SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
    Manufacturer
    SUPERDIMENSION INC.
    Date Cleared
    2012-10-26

    (225 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPERDIMENSION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.
    Device Description
    The superDimension superLock Cobra is an implantable marker intended to be used to radiographically mark soft tissue for future surgical or therapeutic purposes. The marker is placed at or near the intended treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is identified with respect to the marker. The superDimension superLock Cobra is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded delivery cartridge. The device is intended for single use.
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    K Number
    K110093
    Device Name
    SUPERDIMENSION MARKER DELIVERY KIT
    Manufacturer
    SUPERDIMENSION INC.
    Date Cleared
    2011-02-11

    (30 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPERDIMENSION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
    Device Description
    The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
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