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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 K143175
Device Name AEx Generator; PlasmaBlade T
Applicant
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact Deep Pal
Correspondent
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact Deep Pal
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/04/2014
Decision Date 12/31/2014
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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