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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 K172823
Device Name Portex NRFit Epidural Needles
Applicant
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact Sunita Teekasingh
Correspondent
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Correspondent Contact Sunita Teekasingh
Regulation Number868.5150
Classification Product Code
BSP  
Date Received09/18/2017
Decision Date 06/12/2018
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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