ADVANCED UROSCIENCE INNERSHEATH

ADVANCED UROSCIENCE INNERSHEATH is an FDA 510(k)-cleared medical device (K002573) manufactured by Advanced Uroscience, 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 November 15, 2000. Regulation: 8.