510(k) Report

FDA applicant

Erbe Electromedizin GmbH

Dacula, GA2 decisions1990–19950 recalls

FDA records 2 decisions for Erbe Electromedizin GmbH (Dacula, GA) from 1990 to 1995: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 Erbe Electromedizin GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Erbe Electromedizin GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Erbe Electromedizin GmbH 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K953738Erbotom Icc 300Erbe Electromedizin GmbH · 19952cite it

What has FDA decided for it lately?

  • K953738Erbotom Icc 300Erbe Electromedizin GmbH · 1995
  • K896055Erbotom Acc 450Erbe Electromedizin GmbH · 1990

All 2 as Erbe Electromedizin GmbH →

Other applicant names beginning “Erbe”

FDA records each applicant name separately; these may or may not be the same firm.

Erbe USA, Inc. 39Erbe Elektromedizin GmbH 16