FDA 510(k)

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

Número K: K151976 · 2016-06-27

Data da decisão2016-06-27

Código do produtoFAS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Omnitech Systems, Inc.. It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K151976. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K151976.

When did Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode receive FDA 510(k) clearance?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode received FDA 510(k) clearance on 2016-06-27, under 510(k) number K151976.

Who is the listed applicant for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA 510(k) record lists Omnitech Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is FAS.

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