UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
K-Number: K201837 · 2020-07-31
ApplicantNeotract, Inc.
Decision Date2020-07-31
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2020-07-31 under approval number K201837. 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 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Neotract, Inc.. The 510(k) number is K201837.
When was UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge approved by the FDA?
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge received FDA 510(k) clearance on 2020-07-31, under approval number K201837.
What company makes UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is manufactured by Neotract, Inc..
What is the FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?
The FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is PEW.
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Other Devices by Neotract, Inc.
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.
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K193269UroLift System (UL400)Neotract, Inc.
K190377UroLift System UL400Neotract, 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.