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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 K162345
Device Name UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
Applicant
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Applicant Contact LOUIS-PIERRE MARCOUX
Correspondent
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Correspondent Contact LOUIS-PIERRE MARCOUX
Regulation Number876.5530
Classification Product Code
PEW  
Date Received08/22/2016
Decision Date 09/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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