AXIOS Stent and Electrocautery Enhanced Delivery System— 510(k) K163272

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K163272 for AXIOS Stent and Electrocautery Enhanced Delivery System, Substantially Equivalent on 2017-02-18. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2016-11-21
Decision date: 2017-02-18
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.