GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is an FDA 510(k)-cleared medical device (K042427) manufactured by Genemed, 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 December 2, 2004. Regulation: 8.