UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge

Implantable Transprostatic Tissue Retractor System

NeoTract, Inc.

The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift 2 System (formerly Ul500), Urolift 2 Delivery Handle, Urolift 2 Implant Cartridge.

Pre-market Notification Details

Device IDK201837
510k NumberK201837
Device Name:UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
ClassificationImplantable Transprostatic Tissue Retractor System
Applicant NeoTract, Inc. 4155 Hopyard Road Pleasanton,  CA  94588
ContactBrian Gall
CorrespondentBrian Gall
NeoTract, Inc. 4155 Hopyard Road Pleasanton,  CA  94588
Product CodePEW  
CFR Regulation Number876.5530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2020-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20814932020135 K201837 000
20814932020128 K201837 000
10814932020206 K201837 000
20814932020296 K201837 000
20814932020289 K201837 000
20814932020357 K201837 000
20814932020340 K201837 000

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