510(k) Report

FDA applicant

Gynova, LLC

Manchester, CT1 decision2006–20060 recalls

FDA records 1 decision for Gynova, LLC (Manchester, CT) in 2006: 1 510(k) clearance. All are in product code HIB (Speculum, Vaginal, Nonmetal). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Gynova, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynova, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052420G-Spec Articulated Weighted Vaginal SpeculumGynova, LLC · 2006

The one decision as Gynova, LLC →