510(k) Report

FDA applicant

Genii, Inc.

Minneapolis, MN2 decisions2012–20130 recalls

FDA records 2 decisions for Genii, Inc. (Minneapolis, MN) from 2012 to 2013: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 5 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, general and plastic surgery panel, where it files most

How often FDA has decided Genii, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Genii, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 20121cites it

What has FDA decided for it lately?

  • K130983Genii Arc Smart Argon ProbeGenii, Inc. · 2013
  • K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012

All 2 as Genii, Inc. →