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Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

by Zhejiang CuraWay Medical Technology Co., Ltd.

510(k) K232505

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) K232505↗

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 NumberK232505 Date30 May 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  • Withdrawn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.

This device is an Endovenous Radiofrequency Generator and Catheter, classified under the General, Plastic Surgery advisory committee. It delivers controlled radiofrequency energy via a catheter to treat varicose veins by inducing thermal ablation, promoting vein occlusion and subsequent resorption. The system combines a generator and disposable catheter designed for minimally invasive endovenous procedures.

The device is supplied as a reusable generator paired with single-use catheters, intended for use in clinical settings such as outpatient clinics or hospitals. Sterility is maintained through disposable catheter packaging, and the generator requires proper calibration and maintenance per manufacturer instructions. Compliance with FDA 510K clearance and MDR regulations ensures adherence to safety and performance standards. Catheter 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 clinical settings is this device designed for, and how is it typically used?

    This device is designed for use in outpatient clinics or hospitals where minimally invasive endovenous procedures are performed. It consists of a reusable generator paired with single-use catheters that deliver controlled radiofrequency energy to treat varicose veins. The procedure involves inserting the catheter into the affected vein, where the radiofrequency energy induces thermal ablation, leading to vein occlusion and resorption. The system is intended for clinical settings with appropriate sterile environments and trained personnel.

  • Are the catheters reusable or single-use, and how is sterility ensured?

    The catheters are single-use and designed for one-time clinical use only. Sterility is maintained through their disposable packaging, which protects the catheter from contamination before use. This ensures a sterile field during the procedure, reducing infection risks.

  • What regulatory pathways does this device follow, and what does that mean for safety and compliance?

    This device follows both FDA 510K clearance and MDR (Medical Device Regulation) compliance pathways, ensuring it meets established safety and performance standards. The FDA 510K clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device, while MDR compliance ensures adherence to European Union regulations for medical devices. Both pathways involve rigorous review processes to validate the device’s efficacy and safety.

  • How are the catheters sized or configured, and where can I find this information?

    The catheter sizes and configurations are detailed in the accompanying technical documentation provided by the manufacturer. Since specifications like diameters, lengths, or specific models aren’t listed in the public data, you’ll need to refer to the manufacturer’s instructions or catalog for precise details. This ensures clinicians can select the appropriate catheter for their patient’s procedure.

  • What maintenance or calibration is required for the reusable generator?

    The reusable generator requires proper calibration and maintenance as outlined in the manufacturer’s instructions. Since it is a reusable component, adherence to these guidelines is critical to ensure consistent performance, safety, and longevity of the device. Regular maintenance helps prevent malfunctions and ensures the generator delivers accurate radiofrequency energy during procedures.