Women’s healthcare specialist Femasys Inc. has received 510(k) clearance for its FemChec device, which can be used for tubal occlusion confirmation tests in patients who have had tubal procedures for female sterilization.
The contrast media syringe is designed to prevent over-pressurization while filling the uterine cavity and cornu with a fluoroscopic contrast medium for hysterosalpingogram (HSG) procedures. Using patent-pending technology, the device limits the maximum applied intrauterine pressure to 200 mmHg, potentially reducing procedural complications and helping to prevent improperly performed tests.
The manufacturer anticipates that it will begin shipping the devices to U.S. customers in December 2011.
A video demonstrating how the product works is available on the manufacturer’s website…
Product page: FemChec for low pressure HSG