AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System— 510(k) K181905

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K181905 for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System, Substantially Equivalent on 2019-03-25. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2018-07-16
Decision date: 2019-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PCU

product code PCU

Death: 47
Injury: 804
Malfunction: 709
Total: 1,560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.