# K021869: Owl Radiofrequency System, Model Urf-2AP

- Pathway: 510(k) (Special)
- Applicant: Diros Technology, Inc.
- Decided: Jul 1, 2002 after 25 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
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit; (2005), 20 descendants of its own
- K053415: Lesionpoint RF Cannula (2006), 10 descendants of its own
- K060799: Cosman CSK RF Cannula; Cosman RFK RF Cannula (2006), 9 descendants of its own
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4 (2008), 7 descendants of its own
- K080771: Top Neuropole Needle, Model SH, BL, SC, TC (2008), 4 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K021869
Methodology: https://510kreport.com/methodology