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FDA 510(k)

NerveGuard NRFit, NerveGuard LUER

K-Number: K170435 · 2017-07-12

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2017-07-12
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NerveGuard NRFit, NerveGuard LUER is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2017-07-12 under approval number K170435. 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 NerveGuard NRFit, NerveGuard LUER?

NerveGuard NRFit, NerveGuard LUER is a medical device that received FDA 510(k) clearance on 2017-07-12. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K170435.

When was NerveGuard NRFit, NerveGuard LUER approved by the FDA?

NerveGuard NRFit, NerveGuard LUER received FDA 510(k) clearance on 2017-07-12, under approval number K170435.

What company makes NerveGuard NRFit, NerveGuard LUER?

NerveGuard NRFit, NerveGuard LUER is manufactured by PAJUNK GmbH Medizintechnologie.

What is the FDA product code for NerveGuard NRFit, NerveGuard LUER?

The FDA product code for NerveGuard NRFit, NerveGuard LUER 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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