UroLift System (UL400)
K-Number: K193269 · 2019-12-20
ApplicantNeotract, Inc.
Decision Date2019-12-20
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UroLift System (UL400) is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K193269. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UroLift System (UL400)?
UroLift System (UL400) is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Neotract, Inc.. The 510(k) number is K193269.
When was UroLift System (UL400) approved by the FDA?
UroLift System (UL400) received FDA 510(k) clearance on 2019-12-20, under approval number K193269.
What company makes UroLift System (UL400)?
UroLift System (UL400) is manufactured by Neotract, Inc..
What is the FDA product code for UroLift System (UL400)?
The FDA product code for UroLift System (UL400) is PEW.
Other Devices by Neotract, Inc.
K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
K153584NeoTract UroLift System UL500
K173087UroLift System (UL400 and UL500)
K172359UroLift System (UL500)
K190377UroLift System UL400
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
Related Devices (Code: PEW)
K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc.
K153584NeoTract UroLift System UL500Neotract, Inc.
K173087UroLift System (UL400 and UL500)Neotract, Inc.
K172359UroLift System (UL500)Neotract, Inc.
K190377UroLift System UL400Neotract, Inc.
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.