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FDA 510(k)

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

K-Number: K250774 · 2025-06-25

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2025-06-25
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture 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 2025-06-25 under 510(k) number K250774. 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 SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K250774.

When did SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture receive FDA 510(k) clearance?

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250774.

Who is the listed applicant for SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

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 SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

The FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture 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 IIK243525SonoTAP 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 MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK 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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