VISI-FLOW IRRIGATOR

VISI-FLOW IRRIGATOR is an FDA 510(k)-cleared medical device (K832299) manufactured by Convatec, A Division of E.R. Squibb & Sons. 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 25, 1983. Regulation: 8.