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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNETICS MEDICAL PRODUCTS NV

    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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    K Number
    K013501
    Device Name
    IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2001-11-30

    (39 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNETICS MEDICAL PRODUCTS NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa. The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
    Device Description
    Not Found
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    K Number
    K013536
    Device Name
    EMTRAC; DELPHIN; SEMTRAC 2000 SET
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2001-11-30

    (38 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNETICS MEDICAL PRODUCTS NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.
    Device Description
    Not Found
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    K Number
    K013497
    Device Name
    FAS SET #4551
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2001-11-09

    (18 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNETICS MEDICAL PRODUCTS NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A follicle aspiration set used for transvaginal harvesting of oocytes from follicles for IVF and ICSI.
    Device Description
    Not Found
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