FDA 510(k) Application Details - K211806

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K211806
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Venclose, Inc. 2570 N. 1st Street, FL 2, #221 San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Mai-Ly Wilcox 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	06/11/2021
Decision Date	08/03/2021
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