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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clip, implantable
510(k) Number K181488
Device Name LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
Ethicon Endo-Surgery, LLC
475 Calle C Suite 202
Guynabo,  PR  00969
Applicant Contact Sigfrido Delgado
Ethicon Endo-Surgery, Inc
4545 Creek Rd
Cincinnati,  OH  45245
Correspondent Contact Melissa Iwu
Regulation Number878.4300
Classification Product Code
Date Received06/06/2018
Decision Date 10/30/2018
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