MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR

MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR is an FDA 510(k)-cleared medical device (K943191) manufactured by Boston Scientific 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 August 28, 1994. Regulation: 8.