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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 a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2025-06-25 under approval 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. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K250774.

When was SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture approved by the FDA?

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

What company makes SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture is manufactured by PAJUNK GmbH Medizintechnologie.

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.

Related Clinical Trials

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Other Devices by PAJUNK GmbH Medizintechnologie

K160297Tuohy NRFit K160295SPROTTE NRFit, Quincke NRFit K160296SPROTTE SPECIAL NRFit K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles K152952E-Cath K170305Spinal Manometer NRFit; Spinal Manometer LUER

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Related Devices (Code: BSP)

K160297Tuohy NRFitPAJUNK GmbH Medizintechnologie K160295SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie K160296SPROTTE SPECIAL NRFitPAJUNK GmbH Medizintechnologie K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleSpectra Medical Devices, Inc. K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitSolo-Dex, 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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