AXIOS Stent with Electrocautery Enhanced Delivery System— 510(k) K150692

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K150692 for AXIOS Stent with Electrocautery Enhanced Delivery System, Substantially Equivalent on 2015-08-05. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-18
Decision date: 2015-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.