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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 the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2025-06-27 under 510(k) 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. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K243682.

When did SonoPlex STIM; SonoPlex II receive FDA 510(k) clearance?

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

Who is the listed applicant for SonoPlex STIM; SonoPlex II?

The FDA 510(k) record lists PAJUNK GmbH Medizintechnologie as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing PAJUNK GmbH Medizintechnologie as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureK243525SonoTAP and SonoTAP IIK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyK241954SonoBlock; SonoBlock IIK230701Stim2Go

View all 21 devices →

Related Devices (Code: BSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH MedizintechnologieK240253Reach NeedleAerin Medical, Inc.

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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