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FDA 510(k)

GYRUS ENT SOMNOPLASTY GENERATOR

K-Number: K020067 · 2002-04-04

ApplicantGyrus Ent LLC
Decision Date2002-04-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYRUS ENT SOMNOPLASTY GENERATOR 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 2002-04-04 under 510(k) number K020067. 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 GENERATOR?

GYRUS ENT SOMNOPLASTY GENERATOR is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Gyrus Ent LLC. The 510(k) number is K020067.

When did GYRUS ENT SOMNOPLASTY GENERATOR receive FDA 510(k) clearance?

GYRUS ENT SOMNOPLASTY GENERATOR received FDA 510(k) clearance on 2002-04-04, under 510(k) number K020067.

Who is the listed applicant for GYRUS ENT SOMNOPLASTY GENERATOR?

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 GENERATOR?

The FDA product code for GYRUS ENT SOMNOPLASTY GENERATOR is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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