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FDA 510(k)

SonoBlock; SonoBlock II

K-Number: K241954 · 2024-09-11

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2024-09-11
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SonoBlock; SonoBlock 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 2024-09-11 under 510(k) number K241954. 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 SonoBlock; SonoBlock II?

SonoBlock; SonoBlock II is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K241954.

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

SonoBlock; SonoBlock II received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241954.

Who is the listed applicant for SonoBlock; SonoBlock 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 SonoBlock; SonoBlock II?

The FDA product code for SonoBlock; SonoBlock 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.

K243690SonoMSKK243682SonoPlex STIM; SonoPlex IIK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureK243525SonoTAP and SonoTAP IIK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyK230701Stim2Go

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 MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK 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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