510(k) Report

FDA applicant

Cirtec Medical Corporation

Brooklyn Park1 decision2023–20230 recalls

FDA records 1 decision for Cirtec Medical Corporation (Brooklyn Park) in 2023: 1 original PMA approval. All are in product code EZW (Stimulator, Electrical, Implantable, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Cirtec Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cirtec Medical Corporation by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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