FDA 510(k) Application Details - K210651

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K210651
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg 22045 DE Other 510(k) Applications for this Company
Contact	Katharina Campbell Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2021
Decision Date	08/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review