FLOWGUN REUSABLE IRRIGATION PROBES

FLOWGUN REUSABLE IRRIGATION PROBES is an FDA 510(k)-cleared medical device (K935645) manufactured by O.R. Concepts, 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 March 6, 1994. Regulation: 8.