K253747
- 510(k) number
- K253747
- Device name
- Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- Applicant
- Jiangsu Enjosim Medical Technology Co., Ltd. CN
- Product code
- FMF — Syringe, Piston
- Decision date
- 2026-08-14
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253747.pdf
Official FDA record: K253747
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.