# K062758: Owl Urf-3AP

- Pathway: 510(k) (Special)
- Applicant: Diros Technology, Inc.
- Decided: Sep 27, 2006 after 12 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020354 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021869: Owl Radiofrequency System, Model Urf-2AP, Diros Technology, Inc. (2002) Summary page 2.
- K020354: Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International), Baylis Medical Co., Inc. (2002) Summary page 2.

## Most influential descendants
- K093185: Owl Universal RF System Urf-3AP (ML) (2010), 0 descendants of its own

## Indications for use
The OWL Radiofrequency System, Model URF-3AP, 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

Source page: https://510kreport.com/device/K062758
Methodology: https://510kreport.com/methodology