510(k) Report

FDA applicant

Intervene Group Limited

Uxbridge, GB2 decisions2017–20170 recalls

FDA records 2 decisions for Intervene Group Limited (Uxbridge, GB) in 2017: 2 510(k) clearances. Most are in product codes PNR (Enteral Syringes With Enteral Specific…) and FMF (Syringe, Piston). Its devices cite 12 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Intervene Group, Ltd.”.

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 Intervene Group Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Intervene Group Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Intervene”

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