MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 is an FDA 510(k)-cleared medical device (K043027) manufactured by Applied Medical Technology, 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 December 1, 2004. Regulation: 8.