VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR is an FDA 510(k)-cleared medical device (K092033) manufactured by Elmed USA. 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 April 29, 2010. Regulation: 8.