510(k) Report

FDA applicant

3-D Matrix Europe SAS

Caluire Et Cuire, FR4 decisions2024–20260 recalls

FDA records 4 decisions for 3-D Matrix Europe SAS (Caluire Et Cuire, FR) from 2024 to 2026: 4 510(k) clearances. Most are in product codes QAU (Hemostatic Device For Endoscopic…) and PHN (Protective Coating, Mucoadhesive Application…). Its devices cite 4 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 3-D Matrix Europe SAS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 12026 (partial year): 2
2024high 2 (2026) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — 3-D Matrix Europe SAS by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QAUHemostatic Device For Endoscopic Gastrointestinal Use2decisions
  • PHNProtective Coating, Mucoadhesive Application, For The Rectal Mucosa2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K242250PuraStat3-D Matrix Europe SAS · 20242cite it
  • K242634PuraStat3-D Matrix Europe SAS · 20252cite it
  • K253923PuraStat3-D Matrix Europe SAS · 20261cites it
  • K253924PuraStat3-D Matrix Europe SAS · 20261cites it

What has FDA decided for it lately?

  • K253923PuraStat3-D Matrix Europe SAS · 2026
  • K253924PuraStat3-D Matrix Europe SAS · 2026
  • K242634PuraStat3-D Matrix Europe SAS · 2025
  • K242250PuraStat3-D Matrix Europe SAS · 2024

All 4 as 3-D Matrix Europe SAS →