510(k) K253747 ยท FMF Syringe, Piston
Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
| Applicant | Jiangsu Enjosim Medical Technology Co., Ltd., Wu Xi, CN |
| Decision | Substantially Equivalent, Aug 14, 2026 |
| Received | Nov 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253747
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.