Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2023-09-22 under approval 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. It is manufactured by Neotract, Inc.. The 510(k) number is K232558.

When was UroLift 2 ATC Advanced Tissue Control System approved by the FDA?

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

What company makes UroLift 2 ATC Advanced Tissue Control System?

UroLift 2 ATC Advanced Tissue Control System is manufactured by Neotract, Inc..

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.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07108231 Inspiratory Muscle Training in Hospitalized Heart Failure Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35582708 Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries. Regenerative therapy (2022) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

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.

↑