510(k) Report

FDA applicant

Assut Europe S.P.A.

Magliano Dei Marsi, IT3 decisions2002–20170 recalls

FDA records 3 decisions for Assut Europe S.P.A. (Magliano Dei Marsi, IT) from 2002 to 2017: 3 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Assut Europe”.

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 Assut Europe S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Assut Europe S.P.A. 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?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid1decision
  • NEWSuture, Surgical, Absorbable, Polydioxanone1decision
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K150553FilblocAssut Europe · 20161cites it
  • K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A. · 20171cites it

What has FDA decided for it lately?

  • K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A. · 2017
  • K150553FilblocAssut Europe · 2016
  • K021767AssufilAssut Europe S.P.A. · 2002

All 2 as Assut Europe S.P.A. →The one decision as Assut Europe →