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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 K181653
Device Name Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Sigfrido Delgado
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Rubina Dosani
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/22/2018
Decision Date 09/18/2018
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
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