XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM— 510(k) K050103
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K050103 for XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, Substantially Equivalent on 2005-02-16. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood, CA, 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.