510(k) Report

FDA applicant

Thermigen, Inc.

Southlake, TX2 decisions2013–20180 recalls

FDA records 2 decisions for Thermigen, Inc. (Southlake, TX) from 2013 to 2018: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Thermigen, L.L.C”.

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 Thermigen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12018: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Thermigen, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thermigen, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K130689Symphony RF GeneratorThermigen, Inc. · 20134cite it
  • K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C · 20181cites it

What has FDA decided for it lately?

  • K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C · 2018
  • K130689Symphony RF GeneratorThermigen, Inc. · 2013

The one decision as Thermigen, Inc. →The one decision as Thermigen, L.L.C →