FDA 510(k) Application Details - K232558

Device Classification Name	More FDA Info for this Device
510(K) Number	K232558
Device Name	UroLift 2 ATC Advanced Tissue Control System
Applicant	NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Kelsey Krische 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	08/23/2023
Decision Date	09/22/2023
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