Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-12 under approval 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. It is manufactured by Smiths Medical Asd, Inc.. The 510(k) number is K172823.

When was Portex NRFit Epidural Needles approved by the FDA?

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

What company makes Portex NRFit Epidural Needles?

Portex NRFit Epidural Needles is manufactured by Smiths Medical Asd, Inc..

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

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

Other Devices by Smiths Medical Asd, Inc.

K160235ViaValve Safety I.V. Catheter K170720Portex Blue Line Ultra Paediatric Tracheosomy Tube K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit K162219CADD® Infusion Disposables Portfolio with NRFit™ connectors K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit K181699Level 1 Convective Warmer

View all 16 devices →

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.

↑