FDA applicant

Mentor Urology, Inc.

Minneapolis, MN1 decision1997–19970 recalls

FDA records 1 decision for Mentor Urology, Inc. (Minneapolis, MN) in 1997: 1 510(k) clearance. All are in product code FHA (Clamp, Penile). 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 Mentor Urology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mentor 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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Other applicant names beginning “Mentor”

FDA records each applicant name separately; these may or may not be the same firm.

Mentor Corp. 67 Mentor O & O, Inc. 18 Mentor Worldwide, LLC 14 Mentor Ophthalmics, Inc. 4 Mentor Medical Limited 1

Mentor Urology, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Mentor”