510(k) K250774
K250774 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture". The FDA issued a decision of Substantially Equivalent on June 25, 2025. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2025
- Date Received
- March 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type