FDA applicant

Uroplasty, Inc.

Minneapolis, MN9 decisions2005–20120 recalls

FDA records 9 decisions for Uroplasty, Inc. (Minneapolis, MN) from 2005 to 2012: 8 510(k) clearances and 1 original PMA approval. Most are in product codes NAM (Stimulator, Peripheral Nerve, Non-Implanted…) and FBK (Endoscopic Injection Needle…). Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Uroplasty, LLC”.

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 Uroplasty, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Uroplasty, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Uroplasty, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?