K250658
- 510(k) number
- K250658
- Device name
- SureFine Pen Needle
- Applicant
- Shina Med Corporation KR
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-04-03
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250658.pdf
Official FDA record: K250658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.