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Neotract, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2023-09-22
TypeNumberDevice NameCodeDateActions
510(k) K232558 UroLift 2 ATC Advanced Tissue Control SystemPEW2023-09-22 View
510(k) K212396 UroLift System Rigid Retrieval Kit Sterilization TrayKCT2021-10-22 View
510(k) K201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEW2020-07-31 View
510(k) K200441 UroLift Advanced Tissue Control (ATC) SystemPEW2020-06-05 View
510(k) K192781 UroLift System Procedure Kit Sterilization TrayKCT2020-04-14 View
510(k) K193269 UroLift System (UL400)PEW2019-12-20 View
510(k) K190377 UroLift System UL400PEW2019-03-21 View
510(k) K173087 UroLift System (UL400 and UL500)PEW2017-12-28 View
510(k) K172359 UroLift System (UL500)PEW2017-08-18 View
510(k) K162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW2016-09-21 View
510(k) K153584 NeoTract UroLift System UL500PEW2016-03-15 View
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