510(k) Report

FDA applicant

Gynius AB

Stockholm, SE1 decision2014–20140 recalls

FDA records 1 decision for Gynius AB (Stockholm, SE) in 2014: 1 510(k) clearance. All are in product code HEX (Colposcope (And Colpomicroscope)). Its devices cite 4 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 Gynius AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Gynius AB by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HEXColposcope (And Colpomicroscope)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K132423The GynocularGynius AB · 2014

The one decision as Gynius AB →