510(k) Report

FDA applicant

GBUK Group, Ltd.

Selby, GB2 decisions2021–20220 recalls

FDA records 2 decisions for GBUK Group, Ltd. (Selby, GB) from 2021 to 2022: 2 510(k) clearances. Most are in product codes PIF (Gastrointestinal Tubes With Enteral Specific…) and PIO (Enteral Specific Transition Connectors). 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 GBUK Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 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 — GBUK Group, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “GBUK”

FDA records each applicant name separately; these may or may not be the same firm.