Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle— 510(k) K151895
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K151895 for Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle, Substantially Equivalent on 2015-10-22. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FCG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.