FDA applicant

Soprane S.A.

Washington, DC1 decision2000–20000 recalls

FDA records 1 decision for Soprane S.A. (Washington, DC) in 2000: 1 510(k) clearance. All are in product code HEW (Culdoscope (And Accessories)). 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 Soprane S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Soprane S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Soprane S.A.

Which product codes does it file in?

What has FDA decided for it lately?