21 CFR 882.4400 — Generator, Lesion, Radiofrequency
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4400
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | 2 | 37 | 3rd Party |
