K231734
- 510(k) number
- K231734
- Device name
- STERiJECT Low Dead Space, STERiJECT The Invisible Needle
- Applicant
- Tsk Laboratory International Japan KK JP
- Product code
- QNS — Low Dead Space Needle, Single Lumen, Hypodermic
- Decision date
- 2024-03-08
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231734.pdf
Official FDA record: K231734
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.