FDA applicant

Gynavations, Inc.

Malden, MA1 decision2005–20050 recalls

FDA records 1 decision for Gynavations, Inc. (Malden, MA) in 2005: 1 510(k) clearance. All are in product code NBV (Device, Engorgement, Clitoral). 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 Gynavations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynavations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gynavations, Inc.

Which product codes does it file in?

What has FDA decided for it lately?