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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2019-08-21 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K190026.

When did Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) receive FDA 510(k) clearance?

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

Who is the listed applicant for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: BSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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