GORE VIABIL BILILARY ENDOPROSTHESIS— 510(k) K081184
UnknownW.L. Gore & Associates, Inc. Medical Products Div.
FDA 510(k) clearance K081184 for GORE VIABIL BILILARY ENDOPROSTHESIS, Unknown on 2008-07-22. Applicant: W.L. Gore & Associates, Inc. Medical Products Div..
Clearance details
- Applicant
- W.L. Gore & Associates, Inc. Medical Products Div.
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, US
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.