MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS— 510(k) K041032
UnknownOrbus Medical Technologies
FDA 510(k) clearance K041032 for MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS, Unknown on 2004-05-10. Applicant: Orbus Medical Technologies.
Clearance details
- Applicant
- Orbus Medical Technologies
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Fort Lauderdale, FL, 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.