URGENT PC STIMULATOR; URGENT PC LEAD SET

URGENT PC STIMULATOR; URGENT PC LEAD SET is an FDA 510(k)-cleared medical device (K101847) manufactured by Uroplasty, Inc.. 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 October 20, 2010. Regulation: 8.