K233343
- 510(k) number
- K233343
- Device name
- SteriCap Safety Needle; VitreJect Safety Needle
- Applicant
- Ocuject, LLC CA · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2023-11-27
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233343.pdf
Official FDA record: K233343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.