GYRUS PLASMACISION AND PLASMABLEND ELECTRODES

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 Gyrus Plasmacision And Plasmablend Electrodes.

Pre-market Notification Details

Device IDK050460
510k NumberK050460
Device Name:GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 Maple Grove,  MN  55311 -3602
ContactMark A Jenson
CorrespondentMark A Jenson
GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 Maple Grove,  MN  55311 -3602
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-23
Decision Date2005-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925009738 K050460 000
00821925010888 K050460 000
00821925010482 K050460 000
00821925010949 K050460 000

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