GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR

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 General Purpose Electrosurgical Generator.

Pre-market Notification Details

Device IDK050550
510k NumberK050550
Device Name:GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 Maple Grove,  MN  55311 -3602
ContactMark Jensen
CorrespondentMark Jensen
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 Received2005-03-03
Decision Date2005-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925009004 K050550 000

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