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510(k) Data Aggregation

    K Number
    K041237
    Device Name
    ECHOSAMPLER
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2004-09-08

    (120 days)

    Product Code
    HFF
    Regulation Number
    884.1060
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    Product Code :

    HFF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EchoSampler™ is a single-use, sterile, disposable curette for: - Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity - Obtaining histological biopsy of the glandular epithelium and superficial uterine endometrial wall or sample extraction of uterine menstrual content for any of the following: - a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable, - b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms - c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia - d) Identification of specific uterine pathogens by bacterial culturing of uterine samples - e) Inadequate imaging of the endometrium by endovaginal sonography - f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris, - q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts - h) Congenital abnormalities and/or anatomic variants of the uterine cavity - i) Infertility and habitual abortion
    Device Description
    The EchoSampler™ is a single-use, sterile, disposable curette.
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