MODIFIED SPACEMAKER SYSTEM

MODIFIED SPACEMAKER SYSTEM is an FDA 510(k)-cleared medical device (K042412) 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 23, 2004. Regulation: 8.