STONE EXTRACTOR BALLOON CATHETER

STONE EXTRACTOR BALLOON CATHETER is an FDA 510(k)-cleared medical device (K011261) manufactured by Medi-Globe 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 November 16, 2003. Regulation: 8.