Cleared Traditional

SPROTTE? STANDARD (LUER/ NRFit?) Anesthesiology

K241953 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Nov 2024
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K241953 is an FDA 510(k) clearance for the SPROTTE? STANDARD (LUER/ NRFit?) Anesthesiology, 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 November 22, 2024, 142 days after receiving the submission on July 3, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K241953 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2024
Decision Date November 22, 2024
Days to Decision 142 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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