FDA applicant

Phagenesis Limited

Manchester, GB1 decision2022–20220 recalls

FDA records 1 decision for Phagenesis Limited (Manchester, GB) in 2022: 1 De Novo grant. All are in product code QQG (Oropharyngeal Electrical Stimulator). 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, ear, nose and throat panel, where it files most

How often FDA has decided Phagenesis Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Phagenesis Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Phagenesis Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Phagenesis Limited

Which product codes does it file in?

What has FDA decided for it lately?