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Aqua Medical RF Vapor Ablation System

by Aqua Medical, Inc. 2 variants

510(k) K241271

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241271 Date12 Dec 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aqua Medical RF Vapor Ablation System is an electrosurgical, endoscopic unit designed to deliver heated water vapor for tissue ablation. The system utilizes a radiofrequency generator and specialized catheters to provide treatment for diseases throughout the gastrointestinal tract.

This device is regulated under FDA 510K clearance as an electrosurgical, endoscopic device. It is intended for use by clinical professionals in a medical setting, with specific configurations and catheter options available for various endoscopic interventions.

Other devices from Aqua Medical, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Aqua Medical RF Vapor Ablation System?

    This system is an electrosurgical, endoscopic unit designed to perform tissue ablation by delivering heated water vapor. It is intended for use by clinical professionals to treat diseases throughout the gastrointestinal tract.

  • How is the system configured for clinical use?

    The system utilizes a radiofrequency generator paired with specialized catheters. These components are available in specific configurations to support various endoscopic interventions as required by the clinical setting.

  • What is the regulatory status of this device?

    The Aqua Medical RF Vapor Ablation System is regulated under FDA 510K clearance as an electrosurgical, endoscopic device, identified by K-number K241271.