StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection is an FDA 510(k)-cleared medical device (K233645) manufactured by Boston Scientific Corporation -. 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 11, 2023. Regulation: 8.