← Product Code [GXD](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD) · K010202

# OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES (K010202)

_Leslie W. Organ · GXD · Oct 31, 2001 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K010202

## Device Facts

- **Applicant:** Leslie W. Organ
- **Product Code:** [GXD](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD.md)
- **Decision Date:** Oct 31, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4400
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K010202](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K010202)

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