FDA 510(k)

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE

K-Number: K080844 · 2009-08-13

Decision Date2009-08-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K080844. 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 G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE?

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K080844.

When did G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE receive FDA 510(k) clearance?

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE received FDA 510(k) clearance on 2009-08-13, under 510(k) number K080844.

Who is the listed applicant for G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE?

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

What is the FDA product code for G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE?

The FDA product code for G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE 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.