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FDA 510(k)

UroLift 2 ATC Advanced Tissue Control System

K-Number: K232558 · 2023-09-22

ApplicantNeotract, Inc.
Decision Date2023-09-22
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UroLift 2 ATC Advanced Tissue Control 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 2023-09-22 under 510(k) number K232558. 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 ATC Advanced Tissue Control System?

UroLift 2 ATC Advanced Tissue Control System is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Neotract, Inc.. The 510(k) number is K232558.

When did UroLift 2 ATC Advanced Tissue Control System receive FDA 510(k) clearance?

UroLift 2 ATC Advanced Tissue Control System received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232558.

Who is the listed applicant for UroLift 2 ATC Advanced Tissue Control 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 2 ATC Advanced Tissue Control System?

The FDA product code for UroLift 2 ATC Advanced Tissue Control 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.

K212396UroLift 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)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.

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.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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