AEx Generator; PlasmaBlade T

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 Aex Generator; Plasmablade T.

Pre-market Notification Details

Device IDK143175
510k NumberK143175
Device Name:AEx Generator; PlasmaBlade T
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTRONIC ADVANCED ENERGY 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
ContactDeep Pal
CorrespondentDeep Pal
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 Received2014-11-04
Decision Date2014-12-31
Summary:summary

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