FDA applicant

Q Urological Corporation

Needham, MA3 decisions2010–20170 recalls

FDA records 3 decisions for Q Urological Corporation (Needham, MA) from 2010 to 2017: 3 510(k) clearances. All are in product code FAD (Stent, Ureteral). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 Q Urological Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Q Urological Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Q Urological Corporation

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?