MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
Device Facts
| Record ID | K884347 |
|---|---|
| Device Name | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN |
| Applicant | Advanced Surgical Products, Inc. |
| Product Code | GXI · Neurology |
| Decision Date | Dec 27, 1988 |
| 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.