FDA 510(k) Applications Submitted by Brian Gall
| 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. |
| K142138 |
08/05/2014 |
ISO-GARD MASK |
Teleflex Medical, Inc. |
| K162242 |
08/10/2016 |
Comfort Flo Humidification System |
TELEFLEX MEDICAL, INC |
| K192781 |
09/30/2019 |
UroLift System Procedure Kit Sterilization Tray |
NeoTract, Inc. |
| K153010 |
10/14/2015 |
Hudson RCI AquaPak Sterile Prefilled Nebulizers |
Teleflex Medical, Inc. |
| K173280 |
10/16/2017 |
Neonatal ConchaSmart Breathing Circuits |
Teleflex Medical, Inc |
| K193269 |
11/26/2019 |
UroLift System (UL400) |
Neotract, Inc. |
| K143469 |
12/05/2014 |
SOFTECH Plus ETCO2 Cannula |
TELEFLEX MEDICAL, INC. |
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