# K181905: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 25, 2019 after 252 days
- Product code: PCU (Pancreatic Stent, Covered, Metallic, Removable)
- Device class: 2
- Regulation: 21 CFR 876.5015
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970053 (1997). 11 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153088: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System, Boston Scientific Corporation (2015) Summary page 5.
- K163272: AXIOS Stent and Electrocautery Enhanced Delivery System, Boston Scientific Corporation (2017) Summary page 5.

## Most influential descendants
- K192043: AXIOS Stent and Electrocautery Enhanced Delivery System (2019), 2 descendants of its own
- K220112: AXIOS Stent and Electrocautery-Enhanced Delivery System (2022), 1 descendant of its own
- K203132: AXIOS Stent and Electrocautery Enhanced Delivery System (2021), 1 descendant of its own
- K252648: Niti-S SPAXUS Stent (2026), 0 descendants of its own

## Recalls of this device
- Dec 20, 2024 · Class II · Z-1031-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for 
- Dec 20, 2024 · Class II · Z-1030-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for 
- Dec 1, 2020 · Class II · Z-0776-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc
- Dec 1, 2020 · Class II · Z-0773-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc
- Dec 1, 2020 · Class II · Z-0774-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc
- Dec 1, 2020 · Class II · Z-0775-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc
- Dec 1, 2020 · Class II · Z-0777-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc
- Dec 1, 2020 · Class II · Z-0778-2021: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or proc

## Indications for use
The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >6¢m in size, and symptomatic Walled Off Necrosis >6¢m 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/K181905
Methodology: https://510kreport.com/methodology