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

Electrosurgical, Cutting & Coagulation & Accessories

GYRUS MEDICAL LTD.

The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Gyrus G3 System (generator, Assessories, Somnoplasty Electrodes And Plasmacision Electrodes).

Pre-market Notification Details

Device IDK041285
510k NumberK041285
Device Name:GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff,  GB Cf3 0lt
ContactAndrew Dzimitrowicz
CorrespondentAndrew Dzimitrowicz
GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff,  GB Cf3 0lt
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-13
Decision Date2004-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925041370 K041285 000
00821925026735 K041285 000
00821925026728 K041285 000
00821925026711 K041285 000
00821925026704 K041285 000
00821925026698 K041285 000
00821925010864 K041285 000

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