Polyform Synthetic Mesh— 510(k) K171271
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K171271 for Polyform Synthetic Mesh, Substantially Equivalent on 2017-12-15. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code OTO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Adverse events under product code OTO
product code OTO- Injury
- 840
- Total
- 840
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.