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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 K163435
Device Name Entellus Medical Reinforced Anesthesia Needle
Applicant
Entellus Medical, Inc.
3600 Holly Ln. N., Suite 40
Plymouth,  MN  55447
Applicant Contact Megan Bernier
Correspondent
Entellus Medical, Inc.
3600 Holly Ln. N., Suite 40
Plymouth,  MN  55447
Correspondent Contact Karen Peterson
Regulation Number868.5150
Classification Product Code
BSP  
Date Received12/07/2016
Decision Date 04/05/2017
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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