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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K193356
Device Name BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Applicant
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Juma Hoshino
Correspondent
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Juma Hoshino
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/04/2019
Decision Date 03/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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