510(k) Report

FDA applicant

Gvs Spa

Manchester, MI1 decision2006–20060 recalls

FDA records 1 decision for Gvs Spa (Manchester, MI) in 2006: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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 hospital panel, where it files most

How often FDA has decided Gvs Spa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gvs Spa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gvs Spa 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?

  • FPASet, Administration, Intravascular1decision

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.

  • K061115Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop Controller, Model 11216Gvs Spa · 20062cite it

What has FDA decided for it lately?

  • K061115Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop Controller, Model 11216Gvs Spa · 2006

The one decision as Gvs Spa →