UROPASS URETERAL ACCESS SHEATH, MODEL 61224

UROPASS URETERAL ACCESS SHEATH, MODEL 61224 is an FDA 510(k)-cleared medical device (K051593) manufactured by Acmi Corporation. 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 1, 2005. Regulation: 8.