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Radiofrequency Generator System, Cura RF Electrode

by Zhejiang CuraWay Medical Technology Co., Ltd.

510(k) K240758

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240758↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK240758 Date11 Dec 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Radiofrequency Generator System, Cura RF Electrode is a radiofrequency ablation device (product code: GEI) designed to deliver controlled 480 kHz radiofrequency energy for tissue coagulation and ablation. It integrates a generator, disposable Cura RF electrodes, and ancillary components such as a peristaltic pump for electrode cooling, a foot pedal, and a respiratory locator to enhance procedural precision.

This system is intended for use in general and plastic surgery settings, supplied as a reusable generator paired with single-use electrodes. It is sterilized via ethylene oxide and requires proper storage per manufacturer instructions. The device holds FDA 510(k) clearance (K240758) and MDR compliance, with no MRI safety restrictions noted. Electrode sizes and configurations are specified in the accompanying technical documentation.

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Questions

AI-generated answers, 18 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 types of medical procedures is this radiofrequency generator system primarily used for, and in what clinical settings?

    This system is designed for controlled tissue coagulation and ablation using 480 kHz radiofrequency energy, making it suitable for procedures in general and plastic surgery. The integrated features like a respiratory locator and peristaltic pump for electrode cooling enhance precision during surgeries, ensuring safer and more effective outcomes in these specialized settings.

  • Are the Cura RF electrodes reusable or single-use, and how should they be handled after use?

    The Cura RF electrodes are single-use only, paired with a reusable generator. After use, they should be disposed of properly as medical waste. The reusable generator requires ethylene oxide sterilization before reuse, and storage must follow the manufacturer’s guidelines to maintain sterility and functionality.

  • What safety considerations should clinicians be aware of when using this device, particularly regarding MRI compatibility?

    The system does not have MRI safety restrictions noted, meaning it can be used in environments where MRI scans are performed without interference. However, standard precautions for radiofrequency devices should still be followed, such as ensuring proper grounding and avoiding exposure to electromagnetic interference sources.

  • How do I determine the correct electrode size or configuration for a specific procedure?

    The available electrode sizes and configurations are detailed in the accompanying technical documentation provided by the manufacturer. Since specifications vary by application, clinicians should consult this documentation or contact Zhejiang CuraWay Medical Technology Co., Ltd. for guidance on selecting the appropriate electrode for their procedure.