FDA 510(k) Application Details - K222001

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K222001
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	Zhejiang CuraWay Medical Technology Co., Ltd. Building 1, No.600, 21st street, Qiantang New Area Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Xiaoyu Guan Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2022
Decision Date	06/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review