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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K203303
Device Name Emprint SX Ablation Platform with Thermosphere Technology
Applicant
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Liron Bar-Yaakov
Correspondent
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Liron Bar-Yaakov
Regulation Number878.4400
Classification Product Code
NEY  
Date Received11/09/2020
Decision Date 12/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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