510(k) K250584

Rezum System by Boston Scientific Corporation — Product Code KNS

K250584 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Rezum System". The FDA issued a decision of Substantially Equivalent on June 11, 2025. 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 Corporation has at least 10 other 510(k) clearances on record.