FDA 510(k) Application Details - K242286

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K242286
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Guangzhou Aimira Innovation Technology Co, Ltd. No. 902, 9thFloor, Building 9(Self-Compiled), 6# Building Nanjiang Second Road, Zhujiang Street, Nansha District Guangzhou 510660 CN Other 510(k) Applications for this Company
Contact	Wenyang Sun 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	08/02/2024
Decision Date	11/08/2024
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