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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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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, suite 300
austin,  TX  78746
Contact david m. hooper
Regulation Number876.5983
Classification Product Code
QTD  
Date Received09/30/2021
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
Predetermined Change
Control Plan Authorized		 No
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