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 Plasmablade T.

Pre-market Notification Details

Device IDK170610
510k NumberK170610
Device Name:PlasmaBlade T
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 Received2017-03-01
Decision Date2017-04-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.