510(k) Report

FDA applicant

Sc Hennig Enterprises Europe Srl

Western Australia, AU1 decision1999–19990 recalls

FDA records 1 decision for Sc Hennig Enterprises Europe Srl (Western Australia, AU) in 1999: 1 510(k) clearance. All are in product code GBM (Catheter, Urethral). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sc Hennig Enterprises Europe Srl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sc Hennig Enterprises Europe Srl since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sc 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?

  • GBMCatheter, Urethral1decision

What has FDA decided for it lately?

  • K993651O'neil Sterile Field Intermittent Urinary CatheterSc Hennig Enterprises Europe Srl · 1999

The one decision as Sc Hennig Enterprises Europe Srl →