STATARIUS, MODEL 001 003

STATARIUS, MODEL 001 003 is an FDA 510(k)-cleared medical device (K061292) 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 July 2, 2006. Regulation: 8.