510(k) Report

Devices descending from DEN130023

10 later devices reach Urolift System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153584NeoTract UroLift System UL500Neotract, Inc.20168—
+1K133281Neotract Urolift SystemNeotract, Inc.20139—
+2K173087UroLift System (UL400 and UL500)Neotract, Inc.201751
+2K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc.20167—
+3K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.20201—
+3K193269UroLift System (UL400)Neotract, Inc.201911
+3K190377UroLift System UL400Neotract, Inc.20190—
+3K172359UroLift System (UL500)Neotract, Inc.20176—
+4K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.20230—
+4K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.20200—