510(k) K211282

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

K211282 is an FDA 510(k) premarket notification submitted by Aqua Medical, Inc. for the device "Aqua Medical RF Vapor System". The FDA issued a decision of Substantially Equivalent on May 27, 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.