K250774
- 510(k) number
- K250774
- Device name
- SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
- Applicant
- PAJUNK GmbH Medizintechnologie DE
- Product code
- BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)
- Decision date
- 2025-06-25
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250774.pdf
Official FDA record: K250774
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.