K230959
- 510(k) number
- K230959
- Device name
- VitreJect® Needle; OcuSafe® Needle
- Applicant
- Ocuject, LLC CA · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2023-09-14
- Date received
- 2023-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230959.pdf
Official FDA record: K230959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.