FDA 510(k) Application Details - K210394

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K210394
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 US Other 510(k) Applications for this Company
Contact	John Hoffer 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	02/10/2021
Decision Date	05/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review