510(k) K213627

RF Vapor System by Aqua Medical, Inc. — Product Code KNS

K213627 is an FDA 510(k) premarket notification submitted by Aqua Medical, Inc. for the device "RF Vapor System". The FDA issued a decision of Substantially Equivalent on December 17, 2021. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Aqua Medical, Inc. has at least 4 other 510(k) clearances on record.