K250853
- 510(k) number
- K250853
- Device name
- Merit Syringe
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-11-04
- Date received
- 2025-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250853.pdf
Official FDA record: K250853
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.