Skip to content

SonoMSK

by Pajunk GmbH Medizintechnologie

510(k) K243690

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243690 Date1 Jul 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BSP
Device class
Class II
Regulation
21 CFR Part 868.5150
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SonoMSK is a conduction anesthetic needle designed for musculoskeletal and chronic pain injections. Its echogenic properties enable real-time ultrasound visualization of the needle tip during puncture and injection, enhancing procedural accuracy and reducing complications.

This single-use needle is intended for use in ultrasound-guided interventions, such as musculoskeletal and chronic pain therapies. Supplied sterile in a disposable package, it is classified as a Class II medical device under FDA regulations (21 CFR 868.5150). The device is manufactured by Pajunk GmbH Medizintechnologie and is approved for distribution in the United States via a 510(k) clearance.

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →