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Neotract, Inc.

United States·US-PR-000050907

Last updated September 17, 2026

Information

Country
United States
Address
4155 Hopyard Road, Pleasanton, California, United States
Website
www.teleflex.com/emea/en/index.html
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
1-925-401-0700
PRRC Contact
—
EUDAMED SRN
US-PR-000050907
FDA FEI Number
3005791775
DUNS Number
623519464

Catalogue (22)

DeviceModel / ReferenceRegistriesClassStatus
UroLift® 2 UL500-H
FDA UDI
Class IIActive
UroLift UL400-4
FDA UDI
Class IIActive
UroLift® 2 UL500-C
FDA UDI
Class IIActive
UroLift® 2 UL500-H
FDA UDI
Class IIUnknown
UroLift UL400-4
FDA UDI
Class IIActive
UroLift System (UL400 and UL500) K173087
FDA 510(k)
Class IIActive
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge K162345
FDA 510(k)
Class IIActive
Neotract Anchor System Model: Ref 11208 K101252
FDA 510(k)
Class IIActive
UroLift System Rigid Retrieval Kit Sterilization Tray K212396
FDA 510(k)
Class IIActive
UroLift System (UL400) K193269
FDA 510(k)
Class IIActive
UroLift System UL400 K190377
FDA 510(k)
Class IIActive
NeoTract UroLift System UL500 K153584
EUDAMEDFDA 510(k)
Class IIActive
Neotract Anchor K061700
FDA 510(k)
Class IIActive
Urolift System DEN130023
FDA 510(k)
Class IIActive
Neotract Urolift System K133281
FDA 510(k)
Class IIActive
UroLift System Procedure Kit Sterilization Tray K192781
FDA 510(k)
Class IIActive
Neotract Anchor System Model Tas400 K102028
FDA 510(k)
Class IIActive
Neotract Anchor System K073651
FDA 510(k)
Class IIActive
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge K201837
FDA 510(k)
Class IIActive
UroLift Advanced Tissue Control (ATC) System K200441
FDA 510(k)
Class IIActive
UroLift 2 ATC Advanced Tissue Control System K232558
FDA 510(k)
Class IIActive
UroLift System (UL500) K172359
FDA 510(k)
Class IIActive

Related Companies

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No authorised representatives on record.

Importers

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jun 24, 2022Z-1502-2022—open, classified

There is the potential that during implant deployment, the device may not properly deliver a implant.

Jul 6, 2018Z-0598-2019—terminated

Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.