510(k) K251226

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

K251226 is an FDA 510(k) premarket notification submitted by Aqua Medical, Inc. for the device "Aqua Medical RF Vapor Ablation System". The FDA issued a decision of Substantially Equivalent on August 8, 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. Aqua Medical, Inc. has at least 4 other 510(k) clearances on record.