FDA 510(k) Application Details - K240376

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K240376
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi 315301 CN Other 510(k) Applications for this Company
Contact	Guofang Ma 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	02/07/2024
Decision Date	10/04/2024
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