FDA applicant

Urosurge, Inc.

Coralville, IA4 decisions1998–20000 recalls

FDA records 4 decisions for Urosurge, Inc. (Coralville, IA) from 1998 to 2000: 3 510(k) clearances and 1 De Novo grant. Most are in product codes FAD (Stent, Ureteral) and NAM (Stimulator, Peripheral Nerve, Non-Implanted…). 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 Urosurge, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Urosurge, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Urosurge, Inc.

Which product codes does it file in?

What has FDA decided for it lately?