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510(k) Data Aggregation

    K Number
    K180175
    Device Name
    SignalMark Lung Biopsy Site Marker
    Manufacturer
    ViewPoint Medical, Inc.
    Date Cleared
    2018-12-07

    (319 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ViewPoint Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
    Device Description
    The SignalMark Lung Biopsy Site Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in lung tissue biopsy to "mark" the location of the biopsy site. It is intended to be used on adults undergoing percutaneous lung biopsies, in surgical settings, such as hospitals or medical clinics with operating suites. The SignalMark Lung Biopsy Site Marker consists of two components: - Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue. - Marker: Component made of USP-grade porcine gelatin-based hydrogel with methylene blue-colored silicon dioxide microspheres. The marker aids in the visualization of tissue allowing surgeons to readily locate the biopsy site for subsequent tissue or tumor resection.
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