FDA 510(k) Application Details - K231327

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K231327
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Dolan Mills 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	05/08/2023
Decision Date	10/25/2023
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