K242956
- 510(k) number
- K242956
- Device name
- LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
- Applicant
- Ocuject, LLC CA · US
- Product code
- QNS — Low Dead Space Needle, Single Lumen, Hypodermic
- Decision date
- 2024-10-25
- Date received
- 2024-09-25
- 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: K242956.pdf
Official FDA record: K242956
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.