Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is an FDA 510(k)-cleared medical device (K222734) manufactured by Diversatek Healthcare. 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 November 7, 2022. Regulation: 8.