510(k) K172665

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

K172665 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords". The FDA issued a decision of Substantially Equivalent on May 24, 2018. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Wilson-Cook Medical Inc./Cook Endoscopy has at least 6 other 510(k) clearances on record.