K253622
- 510(k) number
- K253622
- Device name
- Safety Pen Needle
- Applicant
- Ningbo Medsun Medical Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-03-18
- Date received
- 2025-11-18
- 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: K253622.pdf
Official FDA record: K253622
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.