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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 K172757
Device Name Valleylab FX8 Electrosurgical Platform
Applicant
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Sharon McDermott
Correspondent
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Sharon McDermott
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/13/2017
Decision Date 11/02/2017
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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