510(k) K192339

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord by Wilson-Cook Medical, Inc. — Product Code KNS

K192339 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord". The FDA issued a decision of Substantially Equivalent on January 30, 2020. 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. has at least 10 other 510(k) clearances on record.