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510(k) Data Aggregation

    K Number
    K150891
    Device Name
    BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
    Date Cleared
    2015-05-01

    (29 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
    BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. and 22Ga. BNX™ ASPIRATION Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.
    Device Description
    The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and 25 gauge. The BNX FNA / SharkCore FNB Systems have an integrated needle protection shield that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks.
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