SILKBridge— 510(k) K260245
Substantially EquivalentKLISBio S.r.l.
FDA 510(k) clearance K260245 for SILKBridge, Substantially Equivalent on 2026-04-09. Applicant: KLISBio S.r.l.. Device class: 2.
Summary
SILKBridge is filed under JXI, nerve cuffs: tubes or wraps placed around an injured peripheral nerve to protect a repair or guide regrowth across a gap. KLISBio works with silk fibroin as a biomaterial, hence the name.
Class II, 21 CFR 882.5275. The Neurology panel reviewed it as a Traditional 510(k).
KLISBio filed from Bresso, near Milan, Italy. Review took 72 days (January 27 to April 9, 2026). That's quick for a biomaterial implant and suggests the comparison to existing nerve cuffs went cleanly.
Clearance details
- Applicant
- KLISBio S.r.l.
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bresso, IT
Recent devices under product code JXI
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