Cleared Traditional

SonoMSK

K243690 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jul 2025
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K243690 is an FDA 510(k) clearance for the SonoMSK, 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 July 1, 2025, 214 days after receiving the submission on November 29, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K243690 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date July 01, 2025
Days to Decision 214 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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