CONSURE STOOL MANAGEMENT SYSTEM

CONSURE STOOL MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K133465) manufactured by Consure Medical Pvt , Ltd.. 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 25, 2014. Regulation: 8.