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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 K171358
Device Name Emprint SX Ablation Platform and Accessories
Applicant
Coviden, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Patti Arndt
Correspondent
Coviden, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Patti Arndt
Regulation Number878.4400
Classification Product Code
NEY  
Date Received05/09/2017
Decision Date 09/01/2017
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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