Skip to content

RF Vapor System

by Aqua Medical, Inc.

510(k) K213627

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 · Special NumberK213627 Date17 Dec 2021ClearedStatusActive

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  • Withdrawn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, 22 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 RF Vapor System is a Unit, Electrosurgical, Endoscopic (With Or Without Accessories) device. It is substantially equivalent to a predicate device and has received FDA 510(k) clearance under product code KNS and regulation number 876.4300.

The system is manufactured by Aqua Medical, Inc. and is intended for use in gastroenterology and urology settings. It is supplied as a reusable system and includes a radiofrequency generator and associated components for endoscopic ablation procedures.

Other devices from Aqua Medical, Inc.

Questions

AI-generated answers, 22 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 RF Vapor System used for?

    The RF Vapor System is intended for use in gastroenterology and urology settings for endoscopic ablation procedures, utilizing a radiofrequency generator and associated components to perform electrosurgical treatments.

  • Is the RF Vapor System reusable or single-use?

    The RF Vapor System is supplied as a reusable system, meaning the radiofrequency generator and associated components are designed for multiple uses after appropriate cleaning and reprocessing, not for single-use disposal.

  • What regulatory clearance does the RF Vapor System have?

    The RF Vapor System has received FDA 510(k) clearance under product code KNS and regulation number 876.4300, confirming it is substantially equivalent to a predicate device.