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Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

by Zhejiang CuraWay Medical Technology Co., Ltd.

510(k) K222001

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) K222001↗

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 NumberK222001 Date8 Jun 2023ClearedStatusActive
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  • Withdrawn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
OAB
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 device is an Irreversible Electroporation Ablation Generator and Irreversible Electroporation Probe, classified as a Low Energy Direct Current Thermal Ablation System under FDA nomenclature. It delivers controlled electrical pulses to induce irreversible electroporation, creating localized tissue ablation without thermal damage, primarily used in soft tissue procedures.

This system is supplied as a reusable generator paired with single-use probes, designed for use in clinical settings such as general and plastic surgery. The probes are sterile, intended for one-time use, and comply with FDA 510(k) clearance and MDR regulations. Sizes and configurations are specified by the probe model numbers, with MRI safety considerations noted in the device specifications.

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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 procedures is this irreversible electroporation system primarily designed for?

    This system is designed for soft tissue procedures in clinical settings such as general and plastic surgery. It uses controlled electrical pulses to create localized tissue ablation without thermal damage, making it suitable for applications where precision and minimal collateral effects are critical.

  • Are the probes for this device single-use or reusable, and how does that affect their sterility?

    The probes are single-use and come sterile, ensuring patient safety and reducing the risk of cross-contamination. This aligns with best practices for invasive medical devices, where sterility is paramount for each procedure.

  • How do I determine the correct probe size or configuration for my procedure?

    The probe sizes and configurations are specified by the model numbers listed in the device specifications. You should refer to the manufacturer’s documentation or consult with their technical support to match the appropriate probe to your clinical needs, ensuring compatibility with your procedure.

  • Does this device have any special considerations for MRI safety?

    Yes, the device specifications include MRI safety considerations, which means the probes and generator may have restrictions or guidelines for use in MRI environments. Always check the manufacturer’s instructions or labeling for specific MRI compatibility details to avoid interference or safety risks.

  • What regulatory pathways does this device follow, and how does that impact its use?

    This device follows both FDA 510(k) clearance and MDR (Medical Device Regulation) pathways, indicating it has undergone evaluations for safety and performance in the respective markets. The FDA’s classification as a Low Energy Direct Current Thermal Ablation System under product code OAB confirms its intended use in controlled clinical settings, ensuring compliance with regulatory standards.