# DEN210045: APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

- Pathway: De Novo (Direct)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Jul 12, 2022 after 285 days
- Product code: QTD (Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss)
- Device class: 2
- Regulation: 21 CFR 876.5983
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232544: Apollo ESG NXT System, Apollo REVISE NXT System (2023), 0 descendants of its own

## Indications for use
The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures. The APOLLO REVISE and REVISE SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

Source page: https://510kreport.com/device/DEN210045
Methodology: https://510kreport.com/methodology