VERASTEP

VERASTEP is an FDA 510(k)-cleared medical device (K012539) manufactured by United States Surgical, A Division of Tyco Healthc. 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 5, 2001. Regulation: 8.