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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 K200146
Device Name HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
Applicant
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Shani Frenkel
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Liron Bar Yaakov
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/22/2020
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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