K260245
- 510(k) number
- K260245
- Device name
- SILKBridge
- Applicant
- KLISBio S.r.l. IT
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2026-04-09
- Date received
- 2026-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260245.pdf
Official FDA record: K260245
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.