FDA applicant

Goulter Medical, Inc.

Concord, CA1 decision1997–19970 recalls

FDA records 1 decision for Goulter Medical, Inc. (Concord, CA) in 1997: 1 510(k) clearance. All are in product code EYZ (System, Urine Drainage, Closed, 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 Goulter Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Goulter Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Goulter Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?