Cleared Traditional

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

K222001 · Zhejiang Curaway Medical Technology Co., Ltd. · General & Plastic Surgery

Jun 2023

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K222001 is an FDA 510(k) clearance for the Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe, a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by Zhejiang Curaway Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 8, 2023, 336 days after receiving the submission on July 7, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K222001 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2022
Decision Date	June 08, 2023
Days to Decision	336 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OAB — Low Energy Direct Current Thermal Ablation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Ablation Of Soft Tissue