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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K222001
Device Name Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
Bldg. 1, #600, 21st St., Qiantang New Area
Hangzhou,  CN 310018
Applicant Contact Xiaoyu Guan
Correspondent
Zhejiang Curaway Medical Technology Co., Ltd.
Bldg. 1, #600, 21st St., Qiantang New Area
Hangzhou,  CN 310018
Correspondent Contact Xiaoyu Guan
Regulation Number878.4400
Classification Product Code
OAB  
Date Received07/07/2022
Decision Date 06/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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