FlexPointer 1.5 Single Use, FlexTube 3 Single Use— 510(k) K200041
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K200041 for FlexPointer 1.5 Single Use, FlexTube 3 Single Use, Substantially Equivalent on 2020-03-10. Applicant: Fiagon GmbH.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code PGW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hennigsdorf, DE
Adverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
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.