510(k) Report

FDA applicant

Hennig Enterprises Europe Srl

Perth, AU2 decisions2003–20030 recalls

FDA records 2 decisions for Hennig Enterprises Europe Srl (Perth, AU) in 2003: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and MEA (Pump, Infusion, Pca). 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 Hennig Enterprises Europe Srl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hennig Enterprises Europe Srl since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hennig Enterprises Europe Srl 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
  • MEAPump, Infusion, Pca1decision

What has FDA decided for it lately?

  • K020424V SETHennig Enterprises Europe Srl · 2003
  • K020421GO Medical Patient Controlled Analgesia DevicesHennig Enterprises Europe Srl · 2003

All 2 as Hennig Enterprises Europe Srl →