Delta III Lithotripter

Delta III Lithotripter is an FDA 510(k)-cleared medical device (K201074) manufactured by Dornier Medtech America, 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 September 2, 2020. Regulation: 8.