K252908
- 510(k) number
- K252908
- Device name
- Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- Applicant
- Sandstone Medical (Suzhou), Inc. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-03-25
- Date received
- 2025-09-12
- 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: K252908.pdf
Official FDA record: K252908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.