MODULITH SLK LITHOTRIPTER

MODULITH SLK LITHOTRIPTER is an FDA 510(k)-cleared medical device (K011700) manufactured by Karl Storz Endoscopy. 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 August 15, 2002. Regulation: 8.