WIJAY EZ-VOID EXTERNAL CATHETER VALVE

WIJAY EZ-VOID EXTERNAL CATHETER VALVE is an FDA 510(k)-cleared medical device (K140562) manufactured by Leomed, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2014. Regulation: 8.