FDA 510(k) Application Details - K240758

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K240758
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Zhejiang CuraWay Medical Technology Co., Ltd. Room 106, Building 1, No. 600, 21st Avenue Baiyang Sub-district, Qiantang New District Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Ruiran Song Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2024
Decision Date	12/11/2024
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