510(k) K201159— WallFlex Colonic Stent System with Anchor Lock Delivery System

Substantially Equivalent

Boston Scientific Corporation

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 2020-04-30
Decision date: 2020-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

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.