Device Classification Name |
endoscopic traction device
|
De Novo Number |
DEN220006 |
Device Name |
ProdiGI |
Requester |
covidien llc |
3062 bunker hill lane |
santa clara,
CA
95054
|
|
Contact |
liron bar yaakov |
|
Regulation Number | 876.4410
|
Classification Product Code |
|
Date Received | 01/14/2022 |
Decision Date | 06/13/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|