CURE CATHETER CLOSED SYSTEM

CURE CATHETER CLOSED SYSTEM is an FDA 510(k)-cleared medical device (K080881) manufactured by Cure Medical, 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 10, 2008. Regulation: 8.