Agile Esophageal OTW Stent System— 510(k) K211960
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K211960 for Agile Esophageal OTW Stent System, Substantially Equivalent on 2021-11-22. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code ESW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Adverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
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.