510(k) Report

FDA applicant

M&T S.R.L.

Rimini, IT4 decisions2017–20240 recalls

FDA records 4 decisions for M&T S.R.L. (Rimini, IT) from 2017 to 2024: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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, general and plastic surgery panel, where it files most

How often FDA has decided M&T S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12019: 12020: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — M&T S.R.L. 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?

  • GEXPowered Laser Surgical Instrument4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 144 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K172413MT ONEM&T S.R.L. · 20172cite it
  • K192856MT OneM&T S.R.L. · 20202cite it
  • K191942MT One DiamondM&T S.R.L. · 20191cites it

What has FDA decided for it lately?

  • K240604Mtone Evo (Mtone Evo)M&T S.R.L. · 2024
  • K192856MT OneM&T S.R.L. · 2020
  • K191942MT One DiamondM&T S.R.L. · 2019
  • K172413MT ONEM&T S.R.L. · 2017

All 4 as M&T S.R.L. →