510(k) · Cleared
ClearedApollo ESG NXT System, Apollo REVISE NXT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Cleared on Sep 18, 2023 as substantially equivalent to DEN210045 (Apollo Endosurgery, Inc., 2022) after a 27-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Sep 18, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- QTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210045 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210045 APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System…Apollo Endosurgery, Inc. · 2022
- This deviceK232544 Apollo ESG NXT System, Apollo REVISE NXT SystemApollo Endosurgery, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE… | Apollo Endosurgery, Inc. | 2022 | — |
| 0 (this device) | K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX SystemSummary page 5…(21 CFR 876.5983) Classification Name Endoscopic suturing device for altering gastric anatomy for weight loss Predicate Devices: DEN210045 –Apollo ESG Sx System, Apollo Revise Sx System Device Description These devices are used to perform gastric remodelling t… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QTD devicesQTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QTD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QTD
Too few QTD 510(k)s in any year since 2007 to give a median.
Recalls per year · QTD
No recall names QTD since 2007.
Adverse event reports per year · QTD
1in 2025
MAUDE reports naming product code QTD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232544: Apollo ESG NXT System, Apollo REVISE NXT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232544
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026