ELLIPSE 4

ELLIPSE 4 is an FDA 510(k)-cleared medical device (K964522) manufactured by Andromeda Medizinische Systeme GmbH. 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 20, 1997. Regulation: 8.