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NeoTract UroLift System UL500

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K153584Ref UL400-4

by Neotract, Inc.

Identity

Trade Name
Urolift System EUDAMED
Device Name
UroLift System EUDAMED
Model / Reference
UL400-4 EUDAMED

Identifiers

Primary DI / UDI-DI
10814932020244 EUDAMED
Basic UDI-DI
08019020000000000000027KC EUDAMED
510(k) Number
K153584 FDA 510(k)
FDA Product Code
PEW FDA 510(k)
EMDN Code
P08030101 TRANS-PROSTATIC URETHRAL PROSTHESES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5530 FDA 510(k)
Regulation Number
876.5530 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
Medical Purpose
The UroLift System is a prostatic implant intended to retract prostate tissue EUDAMED
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

The NeoTract UroLift System UL500 is an Implantable Transprostatic Tissue Retractor System, classified as a Class II device. It is designed to mechanically relieve urinary obstruction caused by benign prostatic hyperplasia (BPH) by lifting and holding prostate tissue out of the urethral lumen, thereby restoring normal urine flow without removing or destroying prostate tissue.

The system comprises a reusable delivery handle and single-use implant cartridges containing permanent implants. It is intended for use in urology and gastroenterology settings under sterile conditions, with each implant cartridge designed for one-time use. The device is authorized under FDA 510(k) clearance (K153584) and EU MDR, adhering to regulatory standards for transprostatic procedures. Implant sizes and configurations are pre-loaded in the cartridges, ensuring compatibility with the delivery system.

Frequently asked questions

What is the NeoTract UroLift System UL500 primarily used for in clinical practice?

The NeoTract UroLift System UL500 is designed to mechanically relieve urinary obstruction caused by benign prostatic hyperplasia (BPH). It achieves this by lifting and holding prostate tissue away from the urethral lumen, thereby restoring normal urine flow without removing or destroying prostate tissue. This makes it a non-ablative treatment option for patients with BPH-related symptoms.

How is the NeoTract UroLift System UL500 supplied, and is it reusable?

The system consists of a reusable delivery handle and single-use implant cartridges. Each cartridge contains permanent implants pre-loaded with specific sizes and configurations, ensuring compatibility with the delivery system. The cartridges are intended for one-time use only, while the delivery handle can be reused across multiple procedures.

What types of clinical settings is the NeoTract UroLift System UL500 intended for, and how should it be handled?

The device is intended for use in urology and gastroenterology settings under sterile conditions. Since the implant cartridges are single-use and the procedure involves transprostatic implantation, strict aseptic techniques must be followed to maintain sterility and ensure patient safety.

Are there different sizes or models of implants available in the NeoTract UroLift System UL500, and how are they determined?

Yes, the NeoTract UroLift System UL500 includes implant cartridges with pre-loaded implants of various sizes and configurations. These are designed to accommodate different patient anatomies and obstruction patterns. The specific sizes and configurations are selected based on the patient’s clinical assessment and are pre-matched to ensure compatibility with the reusable delivery handle.

What regulatory pathways has the NeoTract UroLift System UL500 followed, and what does this mean for its use?

The device has received FDA 510(k) clearance (K153584) and adheres to EU MDR standards, confirming it meets regulatory requirements for transprostatic procedures. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for the intended use in relieving BPH-related urinary obstruction.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NeoTract UroLift System UL500 (K153584) — FDA 510(k) | Innolitics, UroLift 2 System (formerly UL500), UroLift 2… - FDA.report, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neotract, Inc.

Sources (2)

  • FDA 510(k) K153584 24 fields · synced Oct 6, 2026
  • EUDAMED 9b23ceea-7db4-4151-86a3-0756dd3ac69d 61 fields · synced Jul 15, 2026