ICATH, STERILESURE

ICATH, STERILESURE is an FDA 510(k)-cleared medical device (K071496) manufactured by Colorado Catheter Company, 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 August 14, 2007. Regulation: 8.