BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

Electrosurgical, Cutting & Coagulation & Accessories

Covidien, LLC

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Bizact Tonsillectomy Device Advanced Bipolar Tissue Sealer/divider.

Pre-market Notification Details

Device IDK193356
510k NumberK193356
Device Name:BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien, LLC 5920 Longbow Drive Boulder,  CO  80301
ContactJuma Hoshino
CorrespondentJuma Hoshino
Covidien, LLC 5920 Longbow Drive Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelEar Nose & Throat
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-03-02

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