FDA 510(k)

GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR

K-Number: K050550 · 2005-11-09

Decision Date2005-11-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR 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 2005-11-09 under 510(k) number K050550. 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 GENERAL PURPOSE ELECTROSURGICAL GENERATOR?

GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2005-11-09. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K050550.

When did GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2005-11-09, under 510(k) number K050550.

Who is the listed applicant for GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR?

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 GENERAL PURPOSE ELECTROSURGICAL GENERATOR?

The FDA product code for GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR is GEI.

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Other records listing Gyrus Medical, Inc. as applicant

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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.