UroViu’s Uro-V System Gets 510(k) Clearance

The FDA granted 510(k) clearance to UroViu’s Uro-V system, a single-use, handheld diagnostic cystoscope specifically designed for female diagnostic cystoscopy.

The battery-operated device uses a disposable cannula with a reusable handle that includes a video processor, touch panel interface and LCD display.

The tube is equipped with a 140-degree-field-of-view camera with 30-degree deflection and an LED illumination module and shared single channel for fluid infusion.