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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 K141122
FOIA Releasable 510(k) K141122
Device Name HARMONIC SCALLOP BLADE, GENERATOR G11
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact EMILY KRUETZKAMP
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact EMILY KRUETZKAMP
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
HGI   LFL  
Date Received04/30/2014
Decision Date 09/15/2014
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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