UroLift Advanced Tissue Control (ATC) System

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 Advanced Tissue Control (atc) System.

Pre-market Notification Details

Device IDK200441
510k NumberK200441
Device Name:UroLift Advanced Tissue Control (ATC) System
ClassificationImplantable Transprostatic Tissue Retractor System
Applicant NeoTract, Inc. 4155 Hopyard Rd. Pleasanton,  CA  94588
ContactBrian Gall
CorrespondentBrian Gall
NeoTract, Inc. 4155 Hopyard Rd. Pleasanton,  CA  94588
Product CodePEW  
CFR Regulation Number876.5530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-06-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20814932020142 K200441 000
20814932020401 K200441 000

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