FlexPointer 1.5 mm— 510(k) K150473
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K150473 for FlexPointer 1.5 mm, Substantially Equivalent on 2015-04-16. Applicant: Fiagon GmbH. Device class: 2.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hennigsdorf, DE
Recent devices under product code PGW
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- K201472 — VenSure Balloon Device, VenSure Nav Balloon Device
- K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use
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.