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FDA 510(k)

RF Vapor System

K-Number: K213627 · 2021-12-17

ApplicantAqua Medical, Inc.
Decision Date2021-12-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RF Vapor System is a medical device manufactured by Aqua Medical, Inc.. It received FDA 510(k) clearance on 2021-12-17 under approval number K213627. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RF Vapor System?

RF Vapor System is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Aqua Medical, Inc.. The 510(k) number is K213627.

When was RF Vapor System approved by the FDA?

RF Vapor System received FDA 510(k) clearance on 2021-12-17, under approval number K213627.

What company makes RF Vapor System?

RF Vapor System is manufactured by Aqua Medical, Inc..

What is the FDA product code for RF Vapor System?

The FDA product code for RF Vapor System is KNS.

Related Clinical Trials

NCT04838769 REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men ACTIVE_NOT_RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING

Other Devices by Aqua Medical, Inc.

K183595Aqua Medical RF Vapor System K211282Aqua Medical RF Vapor System K241271Aqua Medical RF Vapor Ablation System K251226Aqua Medical RF Vapor Ablation System

Related Devices (Code: KNS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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