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FDA 510(k)

NeoTract UroLift System UL500

K-Number: K153584 · 2016-03-15

ApplicantNeotract, Inc.
Decision Date2016-03-15
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NeoTract UroLift System UL500 is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2016-03-15 under approval number K153584. 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 NeoTract UroLift System UL500?

NeoTract UroLift System UL500 is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Neotract, Inc.. The 510(k) number is K153584.

When was NeoTract UroLift System UL500 approved by the FDA?

NeoTract UroLift System UL500 received FDA 510(k) clearance on 2016-03-15, under approval number K153584.

What company makes NeoTract UroLift System UL500?

NeoTract UroLift System UL500 is manufactured by Neotract, Inc..

What is the FDA product code for NeoTract UroLift System UL500?

The FDA product code for NeoTract UroLift System UL500 is PEW.

Other Devices by Neotract, Inc.

K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge K173087UroLift System (UL400 and UL500) K172359UroLift System (UL500) K193269UroLift System (UL400) K190377UroLift 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. K173087UroLift System (UL400 and UL500)Neotract, Inc. K172359UroLift System (UL500)Neotract, Inc. K193269UroLift System (UL400)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.

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