# K203132: AXIOS Stent and Electrocautery Enhanced Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 15, 2021 after 178 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.
1 later device descends from it; 1 cites it directly.
0 of 14 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
- 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 > 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

Source page: https://510kreport.com/device/K203132
Methodology: https://510kreport.com/methodology