URGENT PC NEUROMODULATION SYSTEM

URGENT PC NEUROMODULATION SYSTEM is an FDA 510(k)-cleared medical device (K052025) 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 16, 2005. Regulation: 8.