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510(k) K251505

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) by Alafair Biosciences — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
May 16, 2025
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 by Alafair Biosciences

  • K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (July 18, 2025)
  • K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (July 17, 2025)
  • K240817 — VersaWrap (June 14, 2024)
  • K232029 — VersaWrap Nerve Protector (November 2, 2023)
  • K213163 — VersaWrap (October 29, 2021)
  • K203600 — VersaWrap (March 9, 2021)
  • K201631 — VersaWrap Nerve Protector (September 14, 2020)
  • K200311 — VersaWrap Tendon Protector (March 6, 2020)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)

Other clearances for product code JXI

  • K253363 — NeuroSpan Bridge (January 17, 2026)
  • 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)
  • K223640 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Ax (April 7, 2023)