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FDA 510(k)

Portex NRFit Epidural Needles

K-Number: K172823 · 2018-06-12

ApplicantSmiths Medical Asd, Inc.
Decision Date2018-06-12
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portex NRFit Epidural Needles is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K172823. 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 Portex NRFit Epidural Needles?

Portex NRFit Epidural Needles is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172823.

When did Portex NRFit Epidural Needles receive FDA 510(k) clearance?

Portex NRFit Epidural Needles received FDA 510(k) clearance on 2018-06-12, under 510(k) number K172823.

Who is the listed applicant for Portex NRFit Epidural Needles?

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

What is the FDA product code for Portex NRFit Epidural Needles?

The FDA product code for Portex NRFit Epidural Needles is BSP.

Other records listing Smiths Medical Asd, Inc. as applicant

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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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