MARIONETTE SA, MODEL 001 001 & 001 002

MARIONETTE SA, MODEL 001 001 & 001 002 is an FDA 510(k)-cleared medical device (K072811) manufactured by Kinetic Surgical, LLC. 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 April 20, 2008. Regulation: 8.