LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS is an FDA 510(k)-cleared medical device (K033335) manufactured by Siemens Medical Solutions USA, 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 November 24, 2003. Regulation: 8.