510(k) K262460

Rezum System by Boston Scientific — Product Code KNS

K262460 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Rezum System". The FDA issued a decision of Substantially Equivalent on September 3, 2026. 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.