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FDA 510(k)

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

K-Number: K172800 · 2018-06-14

ApplicantSmiths Medical Asd, Inc.
Decision Date2018-06-14
Product CodeMIA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is a medical device manufactured by Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K172800. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Smiths Medical Asd, Inc.. The 510(k) number is K172800.

When was Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors approved by the FDA?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors received FDA 510(k) clearance on 2018-06-14, under approval number K172800.

What company makes Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is manufactured by Smiths Medical Asd, Inc..

What is the FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors?

The FDA product code for Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors is MIA.

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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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