FDA applicant

Signum Surgical Limited

Galway, IE1 decision2024–20240 recalls

FDA records 1 decision for Signum Surgical Limited (Galway, IE) in 2024: 1 De Novo grant. All are in product code QML (Anal Fistula Closure Device). 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 Signum Surgical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Signum Surgical Limited by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Signum Surgical Limited

Which product codes does it file in?

What has FDA decided for it lately?