510(k) Report

FDA applicant

Renishaw Mayfield Sarl

Chassieu, FR3 decisions2014–20180 recalls

FDA records 3 decisions for Renishaw Mayfield Sarl (Chassieu, FR) from 2014 to 2018: 3 510(k) clearances. All are in product code HAW (Neurological Stereotaxic Instrument). Its devices cite 2 predicates, 1 of them its own earlier devices. No 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 Renishaw Mayfield Sarl’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2014: 12018: 2
2014high 2 (2018) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Renishaw Mayfield Sarl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132755Neuromate Frameless Gen IIRenishaw Mayfield Sarl · 20141cites it

What has FDA decided for it lately?

  • K181706neuromate Gen IIIRenishaw Mayfield Sarl · 2018
  • K180206neuromate Gen IIIRenishaw Mayfield Sarl · 2018
  • K132755Neuromate Frameless Gen IIRenishaw Mayfield Sarl · 2014

All 3 as Renishaw Mayfield Sarl →