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510(k) Data Aggregation

    K Number
    K093218
    Device Name
    FEMEYE TWO
    Manufacturer
    Date Cleared
    2010-05-18

    (217 days)

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

    FEMSUITE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FemEye Two™ Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: - Abnormal Uterine Bleeding . - Infertility and Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram, ● - Intrauterine Foreign Body . - Amenorrhea ● - Pelvic Pain .
    Device Description
    The FemEye Two™ Hysteroscope is designed as a handheld, low-voltage camera device suitable for use during both in-office as well as in-hospital diagnostic procedures. The FemEye Two is a continuous flow hysteroscope intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The device consists of a hysteroscopic endoscope and is provided sterile for single patient use. It consists of a small diameter, rigid shaft and a handle. The shaft contains a camera and integrated light source as well as an irrigation/working channel port. The nondisposable portion of the FemEye Two is the battery cartridge which powers the device.
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