510(k) Report

FDA applicant

Novocure, GmbH

Baar3 decisions2011–20260 recalls

FDA records 3 decisions for Novocure, GmbH (Baar) from 2011 to 2026: 3 original PMA approvals. Most are in product codes NZK (Stimulator, Low Electric Field, Tumor Treatment) and SDA (Electrical Tumor Treatment Fields For…). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2024

2011: 12024: 12026 (partial year): 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Novocure, GmbH by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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