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510(k) Data Aggregation

    K Number
    K161409
    Device Name
    M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
    Manufacturer
    Mermaid Medical A/S
    Date Cleared
    2016-08-02

    (74 days)

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

    Mermaid Medical A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. (N302) Coaxial Introducer Needle is used as a guiding needle for (N301)
    Device Description
    The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded biopsy instrument with a biopsy needle fitted into a plastic handle. The needle has a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound. The M-Biopsy™ Coaxial Introducer Needle has a trocar stylet and a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound. The device (M-Biopsy™ Semi-Automatic Biopsy Instrument) is sold as a single device and as a set combination (M-Biopsy™ Semi-Automatic Biopsy Instrument and M-Biopsy™ Coaxial Introducer Needle). The M-Biopsy™ Semi-Automatic Biopsy Instrument is used to obtain multiple core biopsy samples from soft tissue such as the liver, kidney, prostate, breast, lymph nodes, etc. The M-Biopsy™ Coaxial Introducer Needle is used as a guiding needle for the M-Biopsy™ Semi-Automatic Biopsy Instrument. The M-Biopsy™ device family can be used as transient use less than 60 minutes. The M-Biopsy™ device family is available from Gauge 14 to Gauge 20 in different lengths ranging from 6 cm to 30 cm. The M-Biopsy™ Semi-Automatic Biopsy Instrument consists of: Mandrill, Needle, House Lit, House base, Spring bushings, Spring, Cannula sledge, Trigger, Protecting sheath and Silicone coating. The M-Biopsy™ Coaxial Introducer Needle consists of: Mandrill, Needle, Luer, Hub, Stopper, Protecting sheath and Silicone coating. The M-Biopsy™ Semi Automatic Instrument and Coaxial Needle (set combination) consists of the above mentioned parts and a 3 Cavity clips to keep the part in place in the pouch.
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