K251722
- 510(k) number
- K251722
- Device name
- ProSeal Transfer Injector (421120, 421130, 421140)
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2025-12-05
- Date received
- 2025-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251722.pdf
Official FDA record: K251722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.