510(k) K172288

Fusion OMNI Sphincterotome by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

K172288 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "Fusion OMNI Sphincterotome". The FDA issued a decision of Substantially Equivalent on April 17, 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.