K231877
- 510(k) number
- K231877
- Device name
- NavaClick Injection System
- Applicant
- Lineage Biomedical, Inc. FL · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2023-11-30
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K231877.pdf
Official FDA record: K231877
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.