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Neotract Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
17
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1502-2022Class IIUroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release ToolJune 24, 2022
Z-0598-2019Class IIUroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool July 6, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K232558UroLift 2 ATC Advanced Tissue Control SystemSeptember 22, 2023
K212396UroLift System Rigid Retrieval Kit Sterilization TrayOctober 22, 2021
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeJuly 31, 2020
K200441UroLift Advanced Tissue Control (ATC) SystemJune 5, 2020
K192781UroLift System Procedure Kit Sterilization TrayApril 14, 2020
K193269UroLift System (UL400)December 20, 2019
K190377UroLift System UL400March 21, 2019
K173087UroLift System (UL400 and UL500)December 28, 2017
K172359UroLift System (UL500)August 18, 2017
K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeSeptember 21, 2016
K153584NeoTract UroLift System UL500March 15, 2016
K133281NEOTRACT UROLIFT SYSTEMDecember 20, 2013
DEN130023UROLIFT SYSTEMSeptember 13, 2013
K102028NEOTRACT ANCHOR SYSTEM MODEL TAS400August 4, 2010
K101252NEOTRACT ANCHOR SYSTEM MODEL: REF 11208July 15, 2010
K073651NEOTRACT ANCHOR SYSTEMFebruary 1, 2008
K061700NEOTRACT ANCHOROctober 26, 2006