FDA 510(k)

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

K-Number: K151976 · 2016-06-27

Decision Date2016-06-27

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Omnitech Systems, Inc.. The 510(k) number is K151976.

When was Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode approved by the FDA?

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

What company makes Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is manufactured by Omnitech Systems, Inc..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.