510(k) Report

FDA applicant

Prostalund AB

Se-223 63 Lund1 decision2002–20020 recalls

FDA records 1 decision for Prostalund AB (Se-223 63 Lund) in 2002: 1 original PMA approval. All are in product code MEQ (System, Hyperthermia, Rf/Microwave (Benign…). 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 Prostalund AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prostalund AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prostalund AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy1decision

What has FDA decided for it lately?

  • P010055Prostalund Coretherm System Microwave Thermotherapy for BPHProstalund AB · 2002

The one decision as Prostalund AB →