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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 a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2020-06-05 under approval 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. It is manufactured by Neotract, Inc.. The 510(k) number is K200441.

When was UroLift Advanced Tissue Control (ATC) System approved by the FDA?

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

What company makes UroLift Advanced Tissue Control (ATC) System?

UroLift Advanced Tissue Control (ATC) System is manufactured by Neotract, Inc..

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.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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) K190377UroLift System UL400

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. K190377UroLift System UL400Neotract, 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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