Aqua Medical RF Vapor System

FDA 510(k) K183595 · Aqua Medical, Inc.

Substantially Equivalent

510(k) numberK183595

Submission

Device name
Aqua Medical RF Vapor System
Applicant
Aqua Medical, Inc.
Santa Ana, CA, US
Received
December 21, 2018
Decision date
June 21, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNS

510(k)DeviceApplicantDecision
K262460Rezum SystemKNS · Traditional Boston Scientific09/03/2026SE
K260962SphincterotomeKNS · Traditional Taewoong Medical Co., Ltd.05/21/2026SE
K252388Vanquish Water Vapor Ablation DeviceKNS · Traditional Francis Medical, Inc.11/26/2025SE
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional Olympus Medical Systems Corporation11/25/2025SE
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional Olympus Medical Systems Corp.10/17/2025SE
K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional Olympus Medical Systems Corporation10/10/2025SE
K251104SureTome™ SW Sphincterotome with DomeTipKNS · Traditional Wilson-Cook Medical09/29/2025SE
K251226Aqua Medical RF Vapor Ablation SystemKNS · Traditional Aqua Medical, Inc.08/08/2025SE
K250584Rezum SystemKNS · Traditional Boston Scientific Corporation06/11/2025SE
K242774SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional Creo Medical, Ltd.06/06/2025SE

More from Creo Medical, Ltd.

510(k)DeviceDecision
K251226Aqua Medical RF Vapor Ablation SystemKNS · Traditional 08/08/2025SE
K241271Aqua Medical RF Vapor Ablation SystemKNS · Traditional 12/12/2024SE
K213627RF Vapor SystemKNS · Special 12/17/2021SE
K211282Aqua Medical RF Vapor SystemKNS · Special 05/27/2021SE

Questions and answers

When was Aqua Medical RF Vapor System cleared by the FDA?

Aqua Medical RF Vapor System (K183595) received a 510(k) decision of Substantially Equivalent on June 21, 2019, 182 days after the submission was received.

What is the product code of K183595?

The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.