UROLOGICAL KIT W/STERILE, WATER-FILL

UROLOGICAL KIT W/STERILE, WATER-FILL is an FDA 510(k)-cleared medical device (K841485) manufactured by Medline Industries, 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 May 8, 1984. Regulation: 8.