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510(k) Data Aggregation

    K Number
    K132384
    Device Name
    U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
    Manufacturer
    ENDOSEC CORPORATION
    Date Cleared
    2014-07-02

    (336 days)

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

    ENDOSEC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The U-Scope 8000 HSC+EMB Cannula is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
    Device Description
    The U-Scope 8000 HSC+EMB Cannula is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable endometrial biopsy cannula (the U-Scope 8000 HSC+EMB cannula) and a reusable HandTower (U-Scope 8000). The disposable U-Scope 8000 HSC+EMB cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. Adjacent to the tip of the cannula is a curette that facilitates collection of tissue during the biopsy procedure. The disposable cannula is sterilized and packaged in a sealed pouch. The HandTower is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the U-Scope 8000 HSC+EMB cannula. The HandTower contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
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