SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774)
Description
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture by PAJUNK GmbH Medizintechnologie, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250774
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | 2024 |
| K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | PAJUNK GmbH Medizintechnologie | 2016 |
Trace the full predicate network for K250774
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.