# DEN230019: AXIOS Stent and Electrocautery-Enhanced Delivery System  (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System  (15mm x 10mm Stent)

- Pathway: De Novo (Direct)
- Applicant: Boston Scientific Corporation
- Decided: Aug 18, 2023 after 144 days
- Product code: QXH (Gallbladder Drainage Stent And Delivery System)
- Device class: 2
- Regulation: 21 CFR 876.5016
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has 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
- K233318: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) (2023), 1 descendant of its own
- K252648: Niti-S SPAXUS Stent (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN230019
Methodology: https://510kreport.com/methodology