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510(k) K162345

Device
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
Applicant
NEOTRACT, INC.
510(k) number
K162345
Product code
PEW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-09-21
Date received
2016-08-22
Regulation
876.5530
Classification name
Implantable Transprostatic Tissue Retractor System
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LOUIS-PIERRE MARCOUX
Address
4473 Willow Rd., Suite 100 Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.2023-09-22
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.2020-07-31
K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.2020-06-05
K193269UroLift System (UL400)Neotract, Inc.2019-12-20
K190377UroLift System UL400Neotract, Inc.2019-03-21
K173087UroLift System (UL400 and UL500)Neotract, Inc.2017-12-28
K172359UroLift System (UL500)Neotract, Inc.2017-08-18
K153584NeoTract UroLift System UL500Neotract, Inc.2016-03-15
K133281NEOTRACT UROLIFT SYSTEMNeotract, Inc.2013-12-20
DEN130023UROLIFT SYSTEMNeotract, Inc.2013-09-13

Legacy Summary#

summary

FDA Review#

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