FDA 510(k) Application Details - K192265

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K192265
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	United States Endoscopy Group, Inc 5976 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Carroll L. Martin 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	08/21/2019
Decision Date	05/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review