FDA 510(k) Application Details - K183134

Device Classification Name	More FDA Info for this Device
510(K) Number	K183134
Device Name	ArcTV Transvaginal Sling System
Applicant	UroCure LLC 4701 North 3rd Street, Suite 110 Minneapolis, MN 55401 US Other 510(k) Applications for this Company
Contact	John Nealon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2018
Decision Date	02/07/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review