DILATING TIP OBTURATOR

DILATING TIP OBTURATOR is an FDA 510(k)-cleared medical device (K012884) manufactured by Applied Medical Resources Corp.. 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 January 16, 2002. Regulation: 8.