Edge Insulated Blade Electrode

Electrosurgical, Cutting & Coagulation & Accessories

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Edge Insulated Blade Electrode.

Pre-market Notification Details

Device IDK210338
510k NumberK210338
Device Name:Edge Insulated Blade Electrode
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien LLC 5920 Longbow Drive Boulder,  CO  80301
ContactMiranda Miles
CorrespondentMiranda Miles
Covidien LLC 5920 Longbow Drive Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-04-15

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