21 CFR 882.5275 — Cuff, Nerve
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5275
Identification
A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXI | Cuff, Nerve | 2 | 40 | Implant |
