Device Classification Name |
orally ingested transient device for constipation
|
De Novo Number |
DEN210052 |
Device Name |
Vibrant System |
Requester |
Vibrant Ltd. |
hakochav p.o. box 516 |
yokneam,
IL
2069206
|
|
Contact |
lior ben tsur |
|
Regulation Number | 876.5940
|
Classification Product Code |
|
Date Received | 11/30/2021 |
Decision Date | 08/26/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|