UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
K-Number: K162345 · 2016-09-21
ApplicantNeotract, Inc.
Decision Date2016-09-21
Product CodePEW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K162345. 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 UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Neotract, Inc.. The 510(k) number is K162345.
When was UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge approved by the FDA?
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge received FDA 510(k) clearance on 2016-09-21, under approval number K162345.
What company makes UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is manufactured by Neotract, Inc..
What is the FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?
The FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is PEW.
Related Clinical Trials
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
NCT06642935
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
ACTIVE_NOT_RECRUITING
NCT07039942
French Prospective Multicentric Study in Real World
RECRUITING
NCT06728059
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
COMPLETED
NCT07458243
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 39892748
Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.
Ophthalmology (2025)
PMID: 39855465
[Review of practices concerning the delivery of an international implant card following the implantation of a medical device].
Annales pharmaceutiques francaises (2025)
PMID: 41966145
From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".
International journal of health policy and management (2025)
PMID: 39726899
How to improve the mechanical safety of a novel spinal implant while saving costs and time.
JOR spine (2024)
Other Devices by Neotract, Inc.
Related Devices (Code: PEW)
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.
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, 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.