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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orally Ingested Transient Device For Constipation
510(k) Number K223031
Device Name Vibrant System
Applicant
Vibrant, Ltd.
Hakochav P.O. Box 516
Yokneam,  IL 2069206
Applicant Contact Martha Bezalel
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Classification Product Code
QTN  
Date Received09/29/2022
Decision Date 01/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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