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510(k) Data Aggregation

    K Number
    K133144
    Device Name
    SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
    Manufacturer
    CrossBay Medical, Inc.
    Date Cleared
    2014-03-19

    (153 days)

    Product Code
    PGK, HFE
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PGK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.
    Device Description
    The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
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    K Number
    K060908
    Device Name
    SONOHYSTEROGRAPHY BIOPSY DEVICE
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2006-06-29

    (87 days)

    Product Code
    PGK, HFF
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    PGK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.
    Device Description
    The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.
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