FDA 510(k) Application Details - K182022

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K182022
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	InControl Medical, LLC 3225 Gateway Road Suite 250 Brookfield, WI 53045 US Other 510(k) Applications for this Company
Contact	Corey Olson Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2018
Decision Date	03/15/2019
Decision	SESK - SUBST EQUIV - KIT
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