HELICAL STONE/FLATWIRE STONE BASKETS

HELICAL STONE/FLATWIRE STONE BASKETS is an FDA 510(k)-cleared medical device (K933260) manufactured by Surgitek. 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 January 10, 1994. Regulation: 8.