Cleared Traditional

SonoTAP and SonoTAP II

K243525 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Mar 2025
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K243525 is an FDA 510(k) clearance for the SonoTAP and SonoTAP 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 March 24, 2025, 130 days after receiving the submission on November 14, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K243525 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2024
Decision Date March 24, 2025
Days to Decision 130 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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