FDA 510(k)

GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420

K-Number: K020778 · 2002-05-28

Decision Date2002-05-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2002-05-28 under 510(k) number K020778. 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 ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420?

GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 is a medical device that received FDA 510(k) clearance on 2002-05-28. The listed applicant is Gyrus Ent LLC. The 510(k) number is K020778.

When did GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 receive FDA 510(k) clearance?

GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 received FDA 510(k) clearance on 2002-05-28, under 510(k) number K020778.

Who is the listed applicant for GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420?

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

What is the FDA product code for GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420?

The FDA product code for GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 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.