# K093185: Owl Universal RF System Urf-3AP (ML)

- Pathway: 510(k) (Traditional)
- Applicant: Diros Technology, Inc.
- Decided: Jan 22, 2010 after 105 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: 2 generations back to K020354 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062758: Owl Urf-3AP, Diros Technology, Inc. (2006) Summary page 2.
- K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD, Baylis Medical Co., Inc. (2007) Summary page 2.

## Indications for use
The DIROS QW™ URF-3AP(ML) LESION GENERATOR is intended for the following: 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 The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery,

Source page: https://510kreport.com/device/K093185
Methodology: https://510kreport.com/methodology