EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

GYRUS MEDICAL, INC.

The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode.

Pre-market Notification Details

Device IDK031079
510k NumberK031079
Device Name:EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis,  MN  55311 -3602
ContactMercedes Bayani
CorrespondentMercedes Bayani
GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis,  MN  55311 -3602
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-04
Decision Date2003-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925010901 K031079 000
00821925010666 K031079 000
00821925009707 K031079 000

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