WallFlex Colonic Stent System with Anchor Lock Delivery System— 510(k) K201159
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K201159 for WallFlex Colonic Stent System with Anchor Lock Delivery System, Substantially Equivalent on 2020-08-17. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code MQR
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- 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, through . 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.