Medical Device Manufacturer · US , Pleasanton , CA

Neotract, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2006
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
1-17 of 17
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558 · PEW
Gastroenterology & Urology · 30d
Cleared Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
K212396 · KCT
General Hospital · 81d
Cleared Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2...
K201837 · PEW
Gastroenterology & Urology · 29d
Cleared Jun 05, 2020
UroLift Advanced Tissue Control (ATC) System
K200441 · PEW
Gastroenterology & Urology · 102d
Cleared Apr 14, 2020
UroLift System Procedure Kit Sterilization Tray
K192781 · KCT
General Hospital · 197d
Cleared Dec 20, 2019
UroLift System (UL400)
K193269 · PEW
Gastroenterology & Urology · 24d
Cleared Mar 21, 2019
UroLift System UL400
K190377 · PEW
Gastroenterology & Urology · 30d
Cleared Dec 28, 2017
UroLift System (UL400 and UL500)
K173087 · PEW
Gastroenterology & Urology · 90d
Cleared Aug 18, 2017
UroLift System (UL500)
K172359 · PEW
Gastroenterology & Urology · 14d
Cleared Sep 21, 2016
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
K162345 · PEW
Gastroenterology & Urology · 30d
Cleared Mar 15, 2016
NeoTract UroLift System UL500
K153584 · PEW
Gastroenterology & Urology · 91d
Cleared Dec 20, 2013
NEOTRACT UROLIFT SYSTEM
K133281 · PEW
Gastroenterology & Urology · 56d
Not Cleared Sep 13, 2013
UROLIFT SYSTEM
DEN130023 · PEW
Gastroenterology & Urology · 190d
Cleared Aug 04, 2010
NEOTRACT ANCHOR SYSTEM MODEL TAS400
K102028 · GAT
General & Plastic Surgery · 16d
Cleared Jul 15, 2010
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
K101252 · GAT
General & Plastic Surgery · 72d
Cleared Feb 01, 2008
NEOTRACT ANCHOR SYSTEM
K073651 · GAT
General & Plastic Surgery · 37d
Cleared Oct 26, 2006
NEOTRACT ANCHOR
K061700 · GAW
General & Plastic Surgery · 132d
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