K251447
- 510(k) number
- K251447
- Device name
- K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- Applicant
- Terumo Europe N.V. BE
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-07-08
- Date received
- 2025-05-09
- 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: K251447.pdf
Official FDA record: K251447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.