
Wilson-Cook Medical
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SureTome SW Sphincterotome with DomeTip is an FDA 510(k)-cleared medical device (K251104) manufactured by Wilson-Cook Medical. 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 28, 2025. Regulation: 8.