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The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. 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 an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal 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.

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.

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.