Portex NRFit Epidural Needles

Needle, Conduction, Anesthetic (w/wo Introducer)

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Nrfit Epidural Needles.

Pre-market Notification Details

Device IDK172823
510k NumberK172823
Device Name:Portex NRFit Epidural Needles
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis,  MN  55442
ContactSunita Teekasingh
CorrespondentSunita Teekasingh
Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis,  MN  55442
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2018-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517079238 K172823 000
35019517075759 K172823 000
35019517075773 K172823 000
55019517075807 K172823 000
35019517075926 K172823 000
35019517076480 K172823 000
35019517078798 K172823 000
35019517079139 K172823 000
35019517079177 K172823 000
35019517075742 K172823 000

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