Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)— 510(k) K150662
Substantially EquivalentYpsomed AG
FDA 510(k) clearance K150662 for Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated), Substantially Equivalent on 2015-06-09. Applicant: Ypsomed AG.
Clearance details
- Applicant
- Ypsomed AG
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Burgdorf, CH
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.