510(k) K252908 ยท FMI Needle, Hypodermic, Single Lumen
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
| Applicant | Sandstone Medical (Suzhou), Inc., Suzhou, CN |
| Decision | Substantially Equivalent, Mar 25, 2026 |
| Received | Sep 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252908
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.