# K192043: AXIOS Stent and Electrocautery Enhanced Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 26, 2019 after 26 days
- Product code: PCU (Pancreatic Stent, Covered, Metallic, Removable)
- Device class: 2
- Regulation: 21 CFR 876.5015
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K970053 (1997). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181905: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System, Boston Scientific Corporation (2019) Summary page 4.

## Most influential descendants
- K220112: AXIOS Stent and Electrocautery-Enhanced Delivery System (2022), 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 symptomatic pancreatic pseudocysts >6cm in size, and symptomatic Walled Off Necrosis >6cm in size, with >70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

Source page: https://510kreport.com/device/K192043
Methodology: https://510kreport.com/methodology