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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K163523
Device Name ECHELON CIRCULAR Powered Stapler
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Carmen Ortiz
Ethicon Endo-Surgery, LLC
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Rubina Dosani
Regulation Number878.4750
Classification Product Code
Date Received12/15/2016
Decision Date 04/18/2017
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