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FDA 510(k)

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles

K-Number: K160294 · 2016-10-21

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2016-10-21
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-10-21 under approval number K160294. 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 NRFit, Quincke NRFit Lumbar Puncture needles?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K160294.

When was SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles approved by the FDA?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles received FDA 510(k) clearance on 2016-10-21, under approval number K160294.

What company makes SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is manufactured by PAJUNK GmbH Medizintechnologie.

What is the FDA product code for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles?

The FDA product code for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is BSP.

Related Clinical Trials

NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING NCT05072483 Natural History Study of CADASIL RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT03568292 Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures SUSPENDED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT06816979 Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer NOT_YET_RECRUITING

Other Devices by PAJUNK GmbH Medizintechnologie

K160297Tuohy NRFit K160295SPROTTE NRFit, Quincke NRFit K160296SPROTTE SPECIAL NRFit K152952E-Cath K170305Spinal Manometer NRFit; Spinal Manometer LUER K170435NerveGuard NRFit, NerveGuard LUER

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Related Devices (Code: BSP)

K160297Tuohy NRFitPAJUNK GmbH Medizintechnologie K160295SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie K160296SPROTTE SPECIAL NRFitPAJUNK 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. K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordSpectra Medical Devices

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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