FDA applicant

Enterasense, Ltd.

Galway, IE1 decision2023–20230 recalls

FDA records 1 decision for Enterasense, Ltd. (Galway, IE) in 2023: 1 De Novo grant. All are in product code QUD (Blood Detection Capsule). 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 Enterasense, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Enterasense, Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Enterasense, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?