BALLOON DILATION HELICAL STONE EXTRACT

BALLOON DILATION HELICAL STONE EXTRACT is an FDA 510(k)-cleared medical device (K831875) manufactured by Vpi. 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 11, 1983. Regulation: 8.