EVADRI BLADDER CONTROL SYSTEMS

EVADRI BLADDER CONTROL SYSTEMS is an FDA 510(k)-cleared medical device (K050483) manufactured by Hollister, Inc.. 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 April 11, 2005. Regulation: 8.