PlasmaBlade UPPP And Suction Coagulator

Electrosurgical, Cutting & Coagulation & Accessories

MEDTRONIC ADVANCED ENERGY

The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Plasmablade Uppp And Suction Coagulator.

Pre-market Notification Details

Device IDK150297
510k NumberK150297
Device Name:PlasmaBlade UPPP And Suction Coagulator
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTRONIC ADVANCED ENERGY 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
ContactLydia Sakakeeny
CorrespondentLydia Sakakeeny
MEDTRONIC ADVANCED ENERGY 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-06
Decision Date2015-05-21
Summary:summary

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