NORTHGATE FLOW ASSIST TUBING FOR UROLOGY

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY is an FDA 510(k)-cleared medical device (K943361) manufactured by Northgate Technologies, 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 September 28, 1995. Regulation: 8.