INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)

INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) is an FDA 510(k)-cleared medical device (K011065) manufactured by Richard Wolf Medical Instruments Corp.. 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 May 8, 2001. Regulation: 8.