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510(k) Data Aggregation

    K Number
    K161507
    Device Name
    Cianna Medical SAVI Scout Reflector and SAVI Scout System
    Manufacturer
    CIANNA MEDICAL, INC.
    Date Cleared
    2016-07-29

    (58 days)

    Product Code
    PDW, PBY
    Regulation Number
    878.4670
    Why did this record match?
    Product Code :

    PDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a lumpectomy site intended for surgical removal.
    Device Description
    SAVI Scout Reflector and SAVI Scout System
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    K Number
    DEN130004
    Device Name
    MOERAE SURGICAL MARKING PEN
    Manufacturer
    MOERAE MATRIX, INC.
    Date Cleared
    2014-12-18

    (591 days)

    Product Code
    PDW
    Regulation Number
    878.4670
    Why did this record match?
    Product Code :

    PDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoPrep Surgical Marking Pen is intended for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft.
    Device Description
    The VasoPrep Surgical Marking Pen is a single patient use sterile prescription use only marker intended for use on veins prior to or during Coronary-Assisted Bypass Graft (CABG) surgery. The marker (Figure 1) consists of a pen body, barrel, wick and cap with a wide chisel style applicator tip for delivery of ink to mark internal tissue. The formulation is non-toxic as used and is comprised of an ink material (FD&C Blue Dye #1) compounded into a carrier material (i.e., solvent). The wide chisel tip can deliver either a thin line of ink for precise marks or can be rotated 90° to deliver a wide stripe of ink.
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    K Number
    K141318
    Device Name
    CIANNA MEDICAL SGS SYSTEM
    Manufacturer
    CIANNA MEDICAL, INC.
    Date Cleared
    2014-08-27

    (99 days)

    Product Code
    PDW, PBY
    Regulation Number
    878.4670
    Why did this record match?
    Product Code :

    PDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 7 days) mark a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SGS System) the SGS Tissue Marker is located and surgically removed with the target tissue. The SGS System is intended only for the non-imaging detection of the "SGS Marker" that has been implanted in a lumpectomy site intended for surgical removal.
    Device Description
    Not Found
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