FDA 510(k) Applications Submitted by Neotract, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190377 |
02/19/2019 |
UroLift System UL400 |
NeoTract, Inc. |
| K200441 |
02/24/2020 |
UroLift Advanced Tissue Control (ATC) System |
NeoTract, Inc. |
| K201837 |
07/02/2020 |
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge |
NeoTract, Inc. |
| K212396 |
08/02/2021 |
UroLift System Rigid Retrieval Kit Sterilization Tray |
NeoTract, Inc. |
| K192781 |
09/30/2019 |
UroLift System Procedure Kit Sterilization Tray |
NeoTract, Inc. |
| K193269 |
11/26/2019 |
UroLift System (UL400) |
Neotract, Inc. |
| K232558 |
08/23/2023 |
UroLift 2 ATC Advanced Tissue Control System |
NeoTract, Inc. |
| K101252 |
05/04/2010 |
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
NEOTRACT, INC. |
| K061700 |
06/16/2006 |
NEOTRACT ANCHOR |
NEOTRACT, INC. |
| K102028 |
07/19/2010 |
NEOTRACT ANCHOR SYSTEM MODEL TAS400 |
NEOTRACT, INC. |
| K172359 |
08/04/2017 |
UroLift System (UL500) |
NeoTract, Inc. |
| K162345 |
08/22/2016 |
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge |
NEOTRACT, INC. |
| K173087 |
09/29/2017 |
UroLift System (UL400 and UL500) |
NeoTract, Inc. |
| DEN130023 |
03/07/2013 |
UROLIFT SYSTEM |
NEOTRACT, INC. |
| K133281 |
10/25/2013 |
NEOTRACT UROLIFT SYSTEM |
NEOTRACT, INC. |
| K153584 |
12/15/2015 |
NeoTract UroLift System UL500 |
NeoTract, Inc. |
| K073651 |
12/26/2007 |
NEOTRACT ANCHOR SYSTEM |
NEOTRACT, INC. |
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