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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K160752
FOIA Releasable 510(k) K160752
Device Name HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Applicant
Ethicon Endo-Suregery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact MARJORIE MEDINA
Correspondent
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Correspondent Contact DAVID LOCKE
Classification Product Code
LFL  
Date Received03/18/2016
Decision Date 06/29/2016
Decision Substantially Equivalent (SESE)
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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