MODIFICATION TO FOSSA URETERAL STONE SWEEPER

MODIFICATION TO FOSSA URETERAL STONE SWEEPER is an FDA 510(k)-cleared medical device (K031292) manufactured by Fossa Medical, 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 May 21, 2003. Regulation: 8.