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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) 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. The listed applicant is Neotract, Inc.. The 510(k) number is K201837.

When did UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge receive FDA 510(k) clearance?

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201837.

Who is the listed applicant for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

The FDA 510(k) record lists Neotract, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Neotract, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232558UroLift 2 ATC Advanced Tissue Control SystemK212396UroLift System Rigid Retrieval Kit Sterilization TrayK200441UroLift Advanced Tissue Control (ATC) SystemK192781UroLift System Procedure Kit Sterilization TrayK193269UroLift System (UL400)K190377UroLift System UL400

View all 11 devices →

Related Devices (Code: PEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.K193269UroLift System (UL400)Neotract, Inc.K190377UroLift System UL400Neotract, Inc.K173087UroLift System (UL400 and UL500)Neotract, Inc.K172359UroLift System (UL500)Neotract, 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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