HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor

Electrosurgical, Cutting & Coagulation & Accessories

Covidien, Llc

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Het Bipolar Electrocautery Forceps, Het Bipolar Electrocautery Monitor.

Pre-market Notification Details

Device IDK200146
510k NumberK200146
Device Name:HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien, Llc 15 Hampshire Street Mansfield,  MA  02048
ContactShani Frenkel
CorrespondentLiron Bar Yaakov
Covidien, Llc 6135 Gunbarrel Avenue Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-22
Decision Date2020-05-07

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