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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 K162047
FOIA Releasable 510(k) K162047
Device Name LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
Applicant
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact CELSO DURAN
Correspondent
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact CELSO DURAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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