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FDA 510(k)

UroLift System UL400

K-Number: K190377 · 2019-03-21

ApplicantNeotract, Inc.
Decision Date2019-03-21
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 2019-03-21 under approval number K190377. 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 2019-03-21. It is manufactured by Neotract, Inc.. The 510(k) number is K190377.

When was UroLift System UL400 approved by the FDA?

UroLift System UL400 received FDA 510(k) clearance on 2019-03-21, under approval number K190377.

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) K193269UroLift System (UL400) K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge

View all 11 devices →

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. K193269UroLift System (UL400)Neotract, 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.

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