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510(k) Data Aggregation

    K Number
    K221965
    Device Name
    FemDx FalloView
    Manufacturer
    FemDx Medsystems, Inc.
    Date Cleared
    2023-03-17

    (255 days)

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

    FemDx Medsystems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.
    Device Description
    The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.
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