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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 K193579
Device Name PlasmaBlade X 3.0S LIGHT
Applicant
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Gina Cunsolo
Correspondent
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Gina Cunsolo
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2019
Decision Date 03/24/2020
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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