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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 K110385
Device Name ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Applicant Contact ASIFA VONHOF
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Correspondent Contact ASIFA VONHOF
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received02/10/2011
Decision Date 03/25/2011
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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