De Novo · Granted
GrantedAXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · QXH Gallbladder Drainage Stent And Delivery System
Granted on Aug 18, 2023 as a new device type through De Novo after a 144-day review. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Aug 18, 2023
- Review
- 144 days
- Class
- Class II
- Product code
- QXH
- Recalls
- None
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceDEN230019 AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm…Boston Scientific Corporation · 2023
- Descendant · cites it directly · 1 of its ownK233318 AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)…Boston Scientific Corporation · 2023 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Class I recalls in this family
- K233318 AXIOS Stent and Electrocautery-Enhanced Delivery…cites it directly · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)… | Boston Scientific Corporation | 2023 | — |
| +1 | K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent… | Boston Scientific Corporation | 2023 | Class I |
| +1 | K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 1 |
| 2026 | 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.
1 device in this family has a Class I recall. 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced…Boston Scientific Corporation · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- Of its descendants, K233318 (Boston Scientific Corporation, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QXH devicesQXH Gallbladder Drainage Stent And Delivery System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXH
Too few QXH 510(k)s in any year since 2007 to give a median.
Recalls per year · QXH
No recall names QXH since 2007.
Adverse event reports per year · QXH
45in 2025
MAUDE reports naming product code QXH, 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 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230019 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230019: AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230019
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