StimuQuik 21G X 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G X 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G X 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G X 15cm (6”) Peripheral Nerve Block Needle, StimuQuik

Needle, Conduction, Anesthetic (w/wo Introducer)

Teleflex Medical

The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Stimuquik 21g X 9cm (3.5”) Peripheral Nerve Block Needle, Stimuquik Echo 21g X 9cm (3.5”) Peripheral Nerve Block Needle, Stimuquik 21g X 15cm (6”) Peripheral Nerve Block Needle, Stimuquik Echo 21g X 15cm (6”) Peripheral Nerve Block Needle, Stimuquik .

Pre-market Notification Details

Device IDK173321
510k NumberK173321
Device Name:StimuQuik 21G X 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G X 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G X 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G X 15cm (6”) Peripheral Nerve Block Needle, StimuQuik
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant Teleflex Medical 3015 Carrington Mill Blvd. Morrisville,  NC  27560
ContactKristen Bisanz
CorrespondentKristen Bisanz
Teleflex Medical 3015 Carrington Mill Blvd. Morrisville,  NC  27560
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-20
Decision Date2018-04-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10801902114126 K173321 000
10801902199635 K173321 000
20801902199601 K173321 000
20801902199649 K173321 000
20801902199588 K173321 000
20801902199595 K173321 000
20801902199618 K173321 000
20801902199625 K173321 000
20801902061168 K173321 000
30801902077869 K173321 000
10801902114119 K173321 000
30801902114106 K173321 000
20801902061151 K173321 000
20801902061175 K173321 000
10801902114096 K173321 000
20801902199571 K173321 000

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