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510(k) Data Aggregation

    K Number
    K053583
    Device Name
    OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
    Date Cleared
    2006-03-31

    (98 days)

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

    OPTIVIA MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Optivia Hysteroscopic Introducer is used to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysteroscopy (Infertility and Pregnancy Wastage, Abnormal Uterine Bleeding, Evaluation of Abnormal Hysterosalpingogram, Intrauterine Foreign Body, Amenorrhea, Pelvic Pain) and Operative Hysteroscopy (Removal opf Submucous Fibroids and Large Polyps, Direct Biopsy, Transection of Intrauterine Adhesions, Submucous Myomectomy, Transection of Intrauterine Septa, Endometrial Ablation). The Optivia Steerable Working Channel is used only in conjunction with the Optivia Hysteroscopic Introducer to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysteroscopy (Infertility and Pregnancy Wastage, Abnormal Uterine Bleeding, Evaluation of Abnormal Hysterosalpingogram, Intrauterine Foreign Body, Amenorrhea, Pelvic Pain) and Operative Hysteroscopy (Removal opf Submucous Fibroids and Large Polyps, Direct Biopsy, Transection of Intrauterine Adhesions, Submucous Myomectomy, Transection of Intrauterine Septa, Endometrial Ablation). The Optivia Steerable Working Channel aids in visualization and gives the health care professional the ability to more precisely control the position of the diagnostic or therapeutic device than is achievable without the Steerable Working Channel.
    Device Description
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