Implantable Transprostatic Tissue Retractor System
FDA product code PEW · Class II (moderate risk) · 21 CFR 876.5530 · Gastroenterology, Urology
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
10510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control SystemPEW · Special | Neotract, Inc. | 09/22/2023SE |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEW · Special | Neotract, Inc. | 07/31/2020SE |
| K200441 | UroLift Advanced Tissue Control (ATC) SystemPEW · Traditional | Neotract, Inc. | 06/05/2020SE |
| K193269 | UroLift System (UL400)PEW · Special | Neotract, Inc. | 12/20/2019SE |
| K190377 | UroLift System UL400PEW · Special | Neotract, Inc. | 03/21/2019SE |
| K173087 | UroLift System (UL400 and UL500)PEW · Traditional | Neotract, Inc. | 12/28/2017SE |
| K172359 | UroLift System (UL500)PEW · Special | Neotract, Inc. | 08/18/2017SE |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW · Special | Neotract, Inc. | 09/21/2016SE |
| K153584 | NeoTract UroLift System UL500PEW · Traditional | Neotract, Inc. | 03/15/2016SE |
| K133281 | Neotract Urolift SystemPEW · Special | Neotract, Inc. | 12/20/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1502-2022 Class II | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release ToolThere is the potential that during implant deployment, the device may not properly deliver a implant. | Neotract Inc | 06/24/2022Open, Classified |
| Z-0598-2019 Class II | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle…Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure… | Neotract Inc | 07/06/2018Terminated |