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510(k) Data Aggregation

    K Number
    K011488
    Device Name
    SPIRABRUSH CX BIOPSY INSTRUMENT
    Manufacturer
    TRYLON CORP.
    Date Cleared
    2002-02-22

    (283 days)

    Product Code
    HFB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.
    Device Description
    The SpiraBrush Cx is a biopsy instrument consisting of a sampling head and a handle. The sampling head is placed directly onto the exocervical lesion or cervical area to be biopsied, and rotated to collect a tissue sample. The head is then snapped off the handle and placed in a preservative solution for laboratory processing.
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