K250510
- 510(k) number
- K250510
- Device name
- Sure-Fine Insulin Syringes
- Applicant
- Shina Med Corporation KR
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-10-15
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250510.pdf
Official FDA record: K250510
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.