SWISS LITHOBREAKER

SWISS LITHOBREAKER is an FDA 510(k)-cleared medical device (K123038) manufactured by E.M.S Electro Medical Systems S.A. 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 January 15, 2013. Regulation: 8.