510(k) Report

FDA applicant

Geyser S.A.

Coudes, FR1 decision2004–20040 recalls

FDA records 1 decision for Geyser S.A. (Coudes, FR) in 2004: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). 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 Geyser S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Geyser S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Geyser S.A. 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?

  • GCJLaparoscope, General & Plastic Surgery1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033644EndoboyGeyser S.A. · 20041cites it

What has FDA decided for it lately?

The one decision as Geyser S.A. →