Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
Device Facts
| Record ID | K242841 |
|---|---|
| Device Name | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) |
| Applicant | ABBOTT MEDICAL |
| Product Code | GXI · Neurology |
| Decision Date | May 27, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4725 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.
