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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 K170381
Device Name Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
Applicant
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact Heather Valley
Correspondent
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact Heather Valley
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/07/2017
Decision Date 09/07/2017
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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