FDA 510(k) Application Details - K201837

Device Classification Name	More FDA Info for this Device
510(K) Number	K201837
Device Name	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
Applicant	NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Brian Gall Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2020
Decision Date	07/31/2020
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