21 CFR 882.4725 — Probe, Radiofrequency Lesion
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4725
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | 2 | 66 | 3rd Party |