K250262
- 510(k) number
- K250262
- Device name
- GO-PEN®
- Applicant
- Go-Pen Aps DK
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-04-24
- Date received
- 2025-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250262.pdf
Official FDA record: K250262
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.