Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102756
    Device Name
    SURECORE BIOPSY DEVICE
    Date Cleared
    2011-11-29

    (432 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEST INNOVATIONS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
    Device Description
    The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1