Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160510
    Device Name
    MAKO 7
    Date Cleared
    2016-06-09

    (106 days)

    Product Code
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    nVision Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.
    Device Description
    The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock. In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface. The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1