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510(k) K032115

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 by Polyganics B.V., — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2003
Date Received
July 9, 2003
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 Polyganics B.V.,

  • K141816 — HEMOPORE (October 23, 2014)
  • K141423 — NASOPORE-FD (August 7, 2014)
  • K112267 — NEUROLAC(R) NERVE GUIDE (October 20, 2011)
  • K070715 — NASOPORE EAR (May 7, 2007)
  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (November 21, 2005)
  • K050573 — NEUROLAC NERVE GUIDE (May 4, 2005)
  • K042811 — VIVOSORB SHEET, MODEL FS01 (November 8, 2004)

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)