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510(k) K260245

SILKBridge by KLISBio S.r.l. — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2026
Date Received
January 27, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Nerve
Device Class
Class II
Regulation Number
882.5275
Review Panel
NE
Submission Type

Other clearances for product code JXI

  • K253363 — NeuroSpan Bridge (January 17, 2026)
  • K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (July 22, 2025)
  • K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (July 17, 2025)
  • K243889 — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 (April 2, 2025)
  • K242113 — Nerve Wrap (07-DW-001-TAB) (April 2, 2025)
  • K233322 — Mochida Nerve Cuff (June 21, 2024)
  • K233533 — NerveTape (February 12, 2024)
  • K230794 — Rebuilder Nerve Guidance Conduit (January 29, 2024)
  • K232029 — VersaWrap Nerve Protector (November 2, 2023)
  • K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Ax (October 12, 2023)