510(k) Report

FDA applicant

Eurolink, LLC

Lynnfield, MA1 decision2001–20011 recall

FDA records 1 decision for Eurolink, LLC (Lynnfield, MA) in 2001: 1 510(k) clearance. All are in product code GXI (Probe, Radiofrequency Lesion). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Eurolink, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eurolink, LLC since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Eurolink, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXIProbe, Radiofrequency Lesion1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011387Neurotherm, Model JK4Eurolink, LLC · 20011cites it

What has FDA decided for it lately?

  • K011387Neurotherm, Model JK4Eurolink, LLC · 20011 recall

The one decision as Eurolink, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K011387NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural…Jul 28, 2008