NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03— 510(k) K032115

Name: FDA 510(k) clearance K032115
Creator: U.S. Food and Drug Administration
Published: 2003-10-10

Substantially Equivalent

Polyganics B.V.,

FDA 510(k) clearance K032115 for NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03, Substantially Equivalent on 2003-10-10. Applicant: Polyganics B.V.,. Device class: 2.

Clearance details

Applicant: Polyganics B.V.,
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2003-07-09
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Groningen, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

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K260245 — SILKBridge2026-04-09
K253363 — NeuroSpan Bridge2026-01-17
K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)2025-07-22
K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)2025-07-17
K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02

More clearances from Polyganics B.V.,

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K141816 — HEMOPORE2014-10-23
K141423 — NASOPORE-FD2014-08-07
K112267 — NEUROLAC(R) NERVE GUIDE2011-10-20
K070715 — NASOPORE EAR2007-05-07
K062540 — NASOPORE EAR, MODELS ND04, ND052006-10-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.