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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K173321
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 21G x 2.5cm (1”) Peripheral Nerve Block Needle
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Kristen Bisanz
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Kristen Bisanz
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received10/20/2017
Decision Date 04/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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