De Novo · Granted
GrantedAPOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX 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
Granted on Jul 12, 2022 as a new device type through De Novo after a 285-day review. 1 later device descends from it.
- Decided
- Jul 12, 2022
- Review
- 285 days
- Class
- Class II
- Product code
- QTD
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN210045 APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System…Apollo Endosurgery, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232544 Apollo ESG NXT System, Apollo REVISE NXT SystemApollo Endosurgery, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232544Apollo ESG NXT System, Apollo REVISE NXT SystemApollo Endosurgery, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE… | Apollo Endosurgery, Inc. | 2022 | — |
| +1 | K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA De Novo 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.
Top candidate predicates for a new QTD device
- #1 K232544 Apollo ESG NXT System, Apollo REVISE NXT Systemscore 6.0 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | 2023 | 0 |
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?
- Of its descendants, K232544 (Apollo Endosurgery, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2022, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210045 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210045: APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210045
Report an extraction error
Are you the manufacturer?
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