K240171
- 510(k) number
- K240171
- Device name
- ProSeal Injector Plus (Model no. 421050)
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2024-03-28
- Date received
- 2024-01-22
- 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: K240171.pdf
Official FDA record: K240171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.