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FDA 510(k)

UroLift Advanced Tissue Control (ATC) System

K-Number: K200441 · 2020-06-05

ApplicantNeotract, Inc.
Decision Date2020-06-05
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UroLift Advanced Tissue Control (ATC) System is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K200441. 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 Advanced Tissue Control (ATC) System?

UroLift Advanced Tissue Control (ATC) System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Neotract, Inc.. The 510(k) number is K200441.

When did UroLift Advanced Tissue Control (ATC) System receive FDA 510(k) clearance?

UroLift Advanced Tissue Control (ATC) System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K200441.

Who is the listed applicant for UroLift Advanced Tissue Control (ATC) System?

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 Advanced Tissue Control (ATC) System?

The FDA product code for UroLift Advanced Tissue Control (ATC) System 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 CartridgeK192781UroLift 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.K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, 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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