510(k) K232633

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter by Boston Scientific — Product Code KNS

K232633 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter". The FDA issued a decision of Substantially Equivalent on November 28, 2023. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Boston Scientific has at least 10 other 510(k) clearances on record.