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510(k) K233322

Mochida Nerve Cuff by Mochida Pharmaceutical Co., Ltd. — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
September 29, 2023
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 Mochida Pharmaceutical Co., Ltd.

  • K852121 — MEDILASER MIC MODEL MEL 440-C;30W (August 20, 1985)
  • K852122 — MEDILASER MIC MODEL MEL-445C, 15W (August 20, 1985)
  • K840739 — MEDILASER-S MEL-444-S (September 20, 1984)

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)
  • 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)