K252518
- 510(k) number
- K252518
- Device name
- DuoprossTM Smart Cap (Type I)
- Applicant
- Duopross Meditech Corporate NY · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-12-17
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252518.pdf
Official FDA record: K252518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.