Neotract, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Neotract, Inc. - FDA 510(k) Cleared Devices
Recent clearances: UroLift 2 ATC Advanced Tissue Control System, UroLift System Rigid Retrieval Kit Sterilization Tray, UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
17
Total
16
Cleared
1
Denied
Neotract, Inc. has 16 FDA 510(k) cleared medical devices. Based in Pleasanton, US.
Last cleared in 2023. Active since 2006. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Neotract, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Neotract, Inc.
17 devices
Cleared
Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
Gastroenterology & Urology
30d
Cleared
Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
General Hospital
81d
Cleared
Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2...
Gastroenterology & Urology
29d
Cleared
Jun 05, 2020
UroLift Advanced Tissue Control (ATC) System
Gastroenterology & Urology
102d
Cleared
Apr 14, 2020
UroLift System Procedure Kit Sterilization Tray
General Hospital
197d
Cleared
Dec 20, 2019
UroLift System (UL400)
Gastroenterology & Urology
24d
Cleared
Mar 21, 2019
UroLift System UL400
Gastroenterology & Urology
30d
Cleared
Dec 28, 2017
UroLift System (UL400 and UL500)
Gastroenterology & Urology
90d
Cleared
Aug 18, 2017
UroLift System (UL500)
Gastroenterology & Urology
14d
Cleared
Sep 21, 2016
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
Gastroenterology & Urology
30d
Cleared
Mar 15, 2016
NeoTract UroLift System UL500
Gastroenterology & Urology
91d
Cleared
Dec 20, 2013
NEOTRACT UROLIFT SYSTEM
Gastroenterology & Urology
56d