Cleared Traditional

SonoPlex STIM; SonoPlex II

K243682 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jun 2025
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K243682 is an FDA 510(k) clearance for the SonoPlex STIM; SonoPlex II, 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 27, 2025, 210 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 K243682 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date June 27, 2025
Days to Decision 210 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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