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FDA 510(k)

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle

K-Number: K173321 · 2018-04-25

ApplicantTeleflex Medical
Decision Date2018-04-25
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2018-04-25 under approval number K173321. 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 StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle?

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle is a medical device that received FDA 510(k) clearance on 2018-04-25. It is manufactured by Teleflex Medical. The 510(k) number is K173321.

When was StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle approved by the FDA?

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle received FDA 510(k) clearance on 2018-04-25, under approval number K173321.

What company makes StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle?

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle is manufactured by Teleflex Medical.

What is the FDA product code for StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle?

The FDA product code for StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle is BSP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT06121232 Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study ACTIVE_NOT_RECRUITING NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING

Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025)

Other Devices by Teleflex Medical

K161758Weck Auto Endo10 Automatic Endoscopic Clip Applier K153470MADgic Laryngo-Tracheal Mucosal Atomization Device K180253Sheridan Endobronchial Tubes K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device K173596Rusch Intermittent Urethral Catheters K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

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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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