URETERAL DILATOR/SHEATH SET

URETERAL DILATOR/SHEATH SET is an FDA 510(k)-cleared medical device (K852793) manufactured by American Edwards Laboratories. 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 8, 1985. Regulation: 8.