21 CFR § 882.5275
Nerve cuff
June 25, 2020
(a) 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).
(b) Classification. Class II (performance standards).