510(k) Report

FDA applicant

Neurent Medical

Galway, IE4 decisions2021–20260 recalls

FDA records 4 decisions for Neurent Medical (Galway, IE) from 2021 to 2026: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 148 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neurent Medical , Ltd.”.

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 Neurent Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 12025: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Neurent Medical by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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