510(k) Report

FDA applicant

Applied Urology, Inc.

Launa Hills, CA13 decisions1990–19930 recalls

FDA records 13 decisions for Applied Urology, Inc. (Launa Hills, CA) from 1990 to 1993: 13 510(k) clearances. Most are in product codes FAD (Stent, Ureteral) and FAS (Electrode, Electrosurgical, Active, Urological). 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 Applied Urology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Urology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Applied Urology, 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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