FDA 510(k)

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

N.º K: K201837 · 2020-07-31

Fecha de decisión2020-07-31

Código de productoPEW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201837. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Neotract, Inc.. The 510(k) number is K201837.

When did UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge receive FDA 510(k) clearance?

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201837.

Who is the listed applicant for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

The FDA 510(k) record lists Neotract, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

The FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is PEW.

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Otros registros que enlistan a Neotract, Inc. como solicitante

K232558UroLift 2 ATC Advanced Tissue Control System K212396UroLift System Rigid Retrieval Kit Sterilization Tray K200441UroLift Advanced Tissue Control (ATC) System K192781UroLift System Procedure Kit Sterilization Tray K193269UroLift System (UL400)K190377UroLift System UL400

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: PEW)

K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.K193269UroLift System (UL400)Neotract, Inc.K190377UroLift System UL400Neotract, Inc.K173087UroLift System (UL400 and UL500)Neotract, Inc.K172359UroLift System (UL500)Neotract, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.