510(k) Report

FDA applicant

Advanced Urological Developments

San Carlos, CA1 decision2004–20040 recalls

FDA records 1 decision for Advanced Urological Developments (San Carlos, CA) in 2004: 1 510(k) clearance. All are in product code HIB (Speculum, Vaginal, Nonmetal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Advanced Urological Developments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Urological Developments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal1decision

What has FDA decided for it lately?

  • K040817Popspek Disposable Adjustable Vaginal SpeculumAdvanced Urological Developments · 2004

The one decision as Advanced Urological Developments →