FDA.reportPublic FDA data

De Novo DEN210045

Device
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
Contact
david m. hooper
De Novo number
DEN210045
Product code
QTD
Regulation
876.5983
Classification name
endoscopic suturing device for altering gastric anatomy for weight loss
Decision
granted (DENG)
Decision date
2022-07-12
Date received
2021-09-30
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
QTD
Device name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5983
Implant
Y
Life sustain/support
N