URETERAL ACCESS SHEATH SET (UASS)

URETERAL ACCESS SHEATH SET (UASS) is an FDA 510(k)-cleared medical device (K022135) manufactured by Boston Scientific 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 September 12, 2002. Regulation: 8.