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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 K163548
Device Name ENSEAL X1 Large Jaw Tissue Sealer
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Marjorie Medina
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact David Locke
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
HGI   LFL  
Date Received12/16/2016
Decision Date 02/14/2017
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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