FDA 510(k) Application Details - K213135

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K213135
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	Chirurgie Innovation Z.A. Les Godets, 3 Rue Des Petits Ruisseaux Verriere le Buisson 91370 FR Other 510(k) Applications for this Company
Contact	Guillaume Noury 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	09/27/2021
Decision Date	03/02/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review