Cleared Traditional

SPROTTE? STANDARD (LUER/ NRFit?) Lumbar Puncture

K250774 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jun 2025
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K250774 is an FDA 510(k) clearance for the SPROTTE? STANDARD (LUER/ NRFit?) Lumbar Puncture, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on June 25, 2025, 103 days after receiving the submission on March 14, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K250774 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2025
Decision Date June 25, 2025
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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