510(k) Report

FDA applicant

Dannoritzer Medizintechnik GmbH & Co. KG

Amsterdam, NL1 decision2006–20061 recall

FDA records 1 decision for Dannoritzer Medizintechnik GmbH & Co. KG (Amsterdam, NL) in 2006: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Dannoritzer Medizintechnik GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dannoritzer Medizintechnik GmbH & Co. KG since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dannoritzer Medizintechnik GmbH & Co. KG 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 & Accessories1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 20061cites it

What has FDA decided for it lately?

  • K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 20061 recall

The one decision as Dannoritzer Medizintechnik GmbH & Co. KG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052759Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar…Aug 6, 2018Class III

Other applicant names beginning “Dannoritzer”

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

Dannoritzer Medical Instruments 1