OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

• K Number: K021869
• Device Name: OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
• Manufacturer: DIROS TECHNOLOGY, INC.
• Date Cleared: 2002-07-01 ( 25 days)
• Product Code: GXD , GXI , GZL
• Regulation Number: 882.4400
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The OWL Radiofrequency System, Model URF-2AP, intended use is for:

1. lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA regarding a 510(k) premarket notification for a device called the "OWL Radiofrequency System, Model URF-2AP." The letter confirms the device's substantial equivalence to previously marketed devices and lists its indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided.

Regulation Number and Section

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).