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FDA 510(k)

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

K-Number: K190026 · 2019-08-21

ApplicantTeleflex Medical
Decision Date2019-08-21
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2019-08-21 under approval number K190026. 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 Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is a medical device that received FDA 510(k) clearance on 2019-08-21. It is manufactured by Teleflex Medical. The 510(k) number is K190026.

When was Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) approved by the FDA?

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) received FDA 510(k) clearance on 2019-08-21, under approval number K190026.

What company makes Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is manufactured by Teleflex Medical.

What is the FDA product code for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

The FDA product code for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is BSP.

Related Clinical Trials

NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING

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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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