FDA 510(k)

GYRUS PLASMACISION AND PLASMABLEND ELECTRODES

K-Number: K050460 · 2005-10-25

Decision Date2005-10-25

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS PLASMACISION AND PLASMABLEND ELECTRODES 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 2005-10-25 under 510(k) number K050460. 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 GYRUS PLASMACISION AND PLASMABLEND ELECTRODES?

GYRUS PLASMACISION AND PLASMABLEND ELECTRODES is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K050460.

When did GYRUS PLASMACISION AND PLASMABLEND ELECTRODES receive FDA 510(k) clearance?

GYRUS PLASMACISION AND PLASMABLEND ELECTRODES received FDA 510(k) clearance on 2005-10-25, under 510(k) number K050460.

Who is the listed applicant for GYRUS PLASMACISION AND PLASMABLEND ELECTRODES?

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 GYRUS PLASMACISION AND PLASMABLEND ELECTRODES?

The FDA product code for GYRUS PLASMACISION AND PLASMABLEND ELECTRODES 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.