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510(k) Data Aggregation

    K Number
    K141894
    Device Name
    SHARKCORE FINE NEEDLE BIOPSY SYSTEM
    Date Cleared
    2014-10-06

    (84 days)

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

    COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
    Device Description
    The SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the instrument channel of an ultrasound imaging endoscope. The system is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The SharkCore™ Fine Needle Biopsy (FNB) System is modular in design consisting of two major components; i.e., a delivery system (Beacon™ EUS Delivery System) and a separate exchangeable needle sub-assembly (SharkCore™ FNB Needle).
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