STS-T LITHOTRIPTER, MODEL STS-T

STS-T LITHOTRIPTER, MODEL STS-T is an FDA 510(k)-cleared medical device (K010900) manufactured by Medstone Intl., 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 April 4, 2001. Regulation: 8.