21 CFR 882.4250 — Device, Surgical, Cryogenic
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4250
Identification
A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | 2 | 23 | 3rd Party |
