510(k) Report

FDA applicant

Bowa-Electronics GmbH & Co. KG

Gomaringen, DE2 decisions2018–20200 recalls

FDA records 2 decisions for Bowa-Electronics GmbH & Co. KG (Gomaringen, DE) from 2018 to 2020: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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, general and plastic surgery panel, where it files most

How often FDA has decided Bowa-Electronics GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Bowa-Electronics GmbH & Co. KG by year, 2018–2026Sources: 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 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 20182cite it
  • K193591ARC 400Bowa-Electronics GmbH & Co. KG · 20201cites it

What has FDA decided for it lately?

  • K193591ARC 400Bowa-Electronics GmbH & Co. KG · 2020
  • K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018

All 2 as Bowa-Electronics GmbH & Co. KG →