COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH is an FDA 510(k)-cleared medical device (K043418) manufactured by Cook Urological, 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 March 30, 2005. Regulation: 8.