FDA 510(k)

EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE

K-Number: K031079 · 2003-05-21

Decision Date2003-05-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K031079. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE?

EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K031079.

When did EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE receive FDA 510(k) clearance?

EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance on 2003-05-21, under 510(k) number K031079.

Who is the listed applicant for EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE?

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

What is the FDA product code for EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE?

The FDA product code for EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE is GEI.

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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.