K250700
- 510(k) number
- K250700
- Device name
- Pen Injector Needle 32.5
- Applicant
- Terumo Corporation JP
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-11-21
- Date received
- 2025-03-07
- 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: K250700.pdf
Official FDA record: K250700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.