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FDA 510(k)

UroLift System Procedure Kit Sterilization Tray

K-Number: K192781 · 2020-04-14

ApplicantNeotract, Inc.
Decision Date2020-04-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UroLift System Procedure Kit Sterilization Tray is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2020-04-14 under approval number K192781. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UroLift System Procedure Kit Sterilization Tray?

UroLift System Procedure Kit Sterilization Tray is a medical device that received FDA 510(k) clearance on 2020-04-14. It is manufactured by Neotract, Inc.. The 510(k) number is K192781.

When was UroLift System Procedure Kit Sterilization Tray approved by the FDA?

UroLift System Procedure Kit Sterilization Tray received FDA 510(k) clearance on 2020-04-14, under approval number K192781.

What company makes UroLift System Procedure Kit Sterilization Tray?

UroLift System Procedure Kit Sterilization Tray is manufactured by Neotract, Inc..

What is the FDA product code for UroLift System Procedure Kit Sterilization Tray?

The FDA product code for UroLift System Procedure Kit Sterilization Tray is KCT.

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Other Devices by Neotract, Inc.

K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge K153584NeoTract UroLift System UL500 K173087UroLift System (UL400 and UL500) K172359UroLift System (UL500) K193269UroLift System (UL400) K190377UroLift System UL400

View all 11 devices →

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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