Colonic Plus Regular, Small, and Straight Shape Hydrokit

Colonic Plus Regular, Small, and Straight Shape Hydrokit is an FDA 510(k)-cleared medical device (K180800) manufactured by Colonic Plus. 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 31, 2018. Regulation: 8.