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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 the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2019-03-21 under 510(k) 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. The listed applicant is Neotract, Inc.. The 510(k) number is K190377.

When did UroLift System UL400 receive FDA 510(k) clearance?

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

Who is the listed applicant for UroLift System UL400?

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 System UL400?

The FDA product code for UroLift System UL400 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 TrayK201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeK200441UroLift Advanced Tissue Control (ATC) SystemK192781UroLift System Procedure Kit Sterilization TrayK193269UroLift 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.K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.K193269UroLift System (UL400)Neotract, 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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