# K232544: Apollo ESG NXT System, Apollo REVISE NXT System

- Pathway: 510(k) (Special)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Sep 18, 2023 after 27 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
Longest line of descent: 1 generation back to DEN210045 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210045: APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System, Apollo Endosurgery, Inc. (2022) Summary page 5.

## Indications for use
The Apollo ESG NXT System is 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 between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures. The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

Source page: https://510kreport.com/device/K232544
Methodology: https://510kreport.com/methodology