510(k) Report

FDA applicant

Dixi Medical

Chaudefontaine, FR3 decisions2017–20219 recalls

FDA records 3 decisions for Dixi Medical (Chaudefontaine, FR) from 2017 to 2021: 3 510(k) clearances. Most are in product codes GZL (Electrode, Depth) and GYC (Electrode, Cortical). Its devices cite 5 predicates, 0 of them its own earlier devices. 9 recalls are 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 Dixi Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2017: 12021: 2
2017high 2 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

9in 2021

2021: 9
2017high 9 (2021) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Dixi Medical by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZLElectrode, Depth2decisions
  • GYCElectrode, Cortical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 20173cite it

What has FDA decided for it lately?

  • K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical · 2021
  • K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical · 2021
  • K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 20179 recalls

All 3 as Dixi Medical →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II
  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II
  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II
  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II
  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II
  • K170959The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Dec 9, 2021Class II