FDA 510(k)

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

K-Number: K041285 · 2004-09-10

Decision Date2004-09-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical , Ltd.. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K041285. 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 G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)?

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Gyrus Medical , Ltd.. The 510(k) number is K041285.

When did GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) receive FDA 510(k) clearance?

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) received FDA 510(k) clearance on 2004-09-10, under 510(k) number K041285.

Who is the listed applicant for GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)?

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

What is the FDA product code for GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)?

The FDA product code for GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) is GEI.

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Other records listing Gyrus Medical , Ltd. as applicant

K003569PLASMAKINETIC ENDOUROLOGY SYSTEM K001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE K994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE K993749GYRUS HYSTEROSCOPIC RESECTOSCOPE K990628GYRUS ENDOUROLOGY SYSTEM K982771GYRUS HYSTEROSCOPIC RESECTOSCOPE

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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.