K251089
- 510(k) number
- K251089
- Device name
- EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
- Applicant
- Exelint International, Co. CA · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-12-12
- Date received
- 2025-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K251089.pdf
Official FDA record: K251089
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.