FDA 510(k) Application Details - K193516

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K193516
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	Gynesonics, Inc 600 Chesapeake Drive Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Diane King Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	KNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2019
Decision Date	05/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review