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510(k) Data Aggregation

    K Number
    K051506
    Device Name
    MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
    Manufacturer
    STERYLAB S.R.L.
    Date Cleared
    2005-07-27

    (50 days)

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

    STERYLAB S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bone and Bone marrow biopsy devices – Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices – Spring-Cut, Bio-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological 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 Sterylab family of biopsy products which include different needles and handles for various procedures. The configurations include manual, semi-automatic and automatic systems. They incorporate various needles styles to optimize capture of the biopsy samples and minimize patient discomfort. The soft tissue devices use a spring-powered mechanism. Some may be used in MRI environments.
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