OMNI SPHINCTEROTOME

OMNI SPHINCTEROTOME is an FDA 510(k)-cleared medical device (K052051) manufactured by Wilson-Cook 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 August 4, 2005. Regulation: 8.