Device Classification Name |
endoscopic suturing device for altering gastric anatomy for weight loss
|
De Novo Number |
DEN210045 |
Device Name |
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System |
Requester |
apollo endosurgery, inc. |
1120 s. capital of texas hwy., bldg 1, ste 300 |
austin,
TX
78746
|
|
Contact |
david m. hooper |
|
Regulation Number | 876.5983
|
Classification Product Code |
|
Date Received | 09/30/2021 |
Decision Date | 07/12/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|