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OWL URF-3AP Radiofrequency Lesion Generator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062758

by Diros Technology, Inc.

Identifiers

510(k) Number
K062758 FDA 510(k)
FDA Product Code
GXD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4400 FDA 510(k)
Regulation Number
882.4400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OWL URF-3AP is a radiofrequency lesion generator designed for neurosurgical and interventional pain management procedures. It delivers controlled thermal energy to create targeted tissue lesions via monopolar or bipolar modes, facilitating precise ablation of neural structures for therapeutic relief or surgical intervention.

This device is supplied as a reusable medical instrument, intended for use in sterile operating environments or procedural suites. It operates within Class II regulatory classification under FDA 510(k) clearance (K062758) and adheres to radiofrequency safety standards for neurological applications. The generator may be paired with accessories like the Multilesion Adapter (MLA-4) for simultaneous control of multiple probes, though its primary function remains lesion generation. No MRI compatibility or single-use specifications are indicated.

Frequently asked questions

What types of procedures is the OWL URF-3AP primarily used for, and how does it achieve its therapeutic effect?

The OWL URF-3AP is designed for neurosurgical and interventional pain management procedures, where it delivers controlled radiofrequency (RF) thermal energy to create targeted tissue lesions. By operating in monopolar or bipolar modes, it enables precise ablation of neural structures, which helps provide therapeutic relief or facilitate surgical interventions by disrupting problematic nerve pathways.

Is the OWL URF-3AP a single-use or reusable device, and what considerations should be taken for its use in sterile environments?

The OWL URF-3AP is a reusable medical instrument, meaning it is intended for repeated use in sterile operating environments or procedural suites. Since it is not single-use, proper sterilization protocols must be followed between procedures to ensure patient safety and device integrity.

Can the OWL URF-3AP be used with additional accessories, and if so, what is their purpose?

Yes, the OWL URF-3AP can be paired with accessories like the Multilesion Adapter (MLA-4), which allows for simultaneous control of multiple RF probes. While the primary function remains lesion generation, this accessory enhances versatility by enabling coordinated ablation across multiple sites during a procedure.

What regulatory pathway was followed for the OWL URF-3AP’s clearance, and what does this mean for its use in clinical settings?

The OWL URF-3AP was cleared through the FDA’s 510(k) pathway, specifically under a Special classification (K062758) and determined to be substantially equivalent to a predicate device. This means it adheres to FDA safety and performance standards for radiofrequency lesion generators in neurological applications, ensuring its use aligns with regulatory requirements for neurosurgical and pain management procedures.

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: URF-3AP | Diros Technology | Radiofrequency (RF) Pain Management, PDF Microsoft Word - URF-3AP(ML) Manual Rev. 7.0 - dirostech.com, Diros OWL® URF-3AP RF Lesion Generator, Diros Technology Inc. - OWL URF-3AP Community, Manuals and ... - MedWrench, Diros OWL URF-3AP RF Generator | Prime Medical Concept

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diros Technology, Inc.

Sources (1)

  • FDA 510(k) K062758 24 fields · synced Sep 19, 2026