SILKBridge
Device Facts
| Record ID | K260245 |
|---|---|
| Device Name | SILKBridge |
| Applicant | KLISBio S.r.l. |
| Product Code | JXI · Neurology |
| Decision Date | Apr 9, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5275 |
| Device Class | Class 2 |
Regulatory Classification
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).
