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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K162388
Device Name CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
Applicant
Curaseal, Inc.
2231 Calle De Luna
Santa Clara,  CA  95054
Applicant Contact HAROLD F. CARRISON
Correspondent
Experien Group, LLC
755 N. Mathilda Ave.
Sunnyvale,  CA  94085
Correspondent Contact KIT CARIQUITAN
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received08/25/2016
Decision Date 02/03/2017
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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