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FDA 510(k)

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology

K-Number: K241953 · 2024-11-22

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2024-11-22
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2024-11-22 under approval number K241953. 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®) Anesthesiology?

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K241953.

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

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology received FDA 510(k) clearance on 2024-11-22, under approval number K241953.

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

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

What is the FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

The FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is BSP.

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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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