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FDA 510(k)

SonoPlex STIM; SonoPlex II

K-Number: K243682 · 2025-06-27

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2025-06-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SonoPlex STIM; SonoPlex II is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2025-06-27 under approval number K243682. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SonoPlex STIM; SonoPlex II?

SonoPlex STIM; SonoPlex II is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K243682.

When was SonoPlex STIM; SonoPlex II approved by the FDA?

SonoPlex STIM; SonoPlex II received FDA 510(k) clearance on 2025-06-27, under approval number K243682.

What company makes SonoPlex STIM; SonoPlex II?

SonoPlex STIM; SonoPlex II is manufactured by PAJUNK GmbH Medizintechnologie.

What is the FDA product code for SonoPlex STIM; SonoPlex II?

The FDA product code for SonoPlex STIM; SonoPlex II is BSP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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