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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Transprostatic Tissue Retractor System
510(k) Number K153584
Device Name NeoTract UroLift System UL500
Applicant
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Applicant Contact Nancy E Isaac
Correspondent
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Correspondent Contact Nancy E Isaac
Regulation Number876.5530
Classification Product Code
PEW  
Date Received12/15/2015
Decision Date 03/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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