FDA 510(k)

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge

Número K: K162345 · 2016-09-21

Data da decisão2016-09-21

Código do produtoPEW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162345. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Neotract, Inc.. The 510(k) number is K162345.

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

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162345.

Who is the listed applicant for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

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 System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

The FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is PEW.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Neotract, Inc. como candidato(a)

K232558UroLift 2 ATC Advanced Tissue Control System K212396UroLift System Rigid Retrieval Kit Sterilization Tray K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge K200441UroLift Advanced Tissue Control (ATC) System K192781UroLift System Procedure Kit Sterilization Tray K193269UroLift System (UL400)

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: PEW)

K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.K193269UroLift System (UL400)Neotract, Inc.K190377UroLift System UL400Neotract, Inc.K173087UroLift System (UL400 and UL500)Neotract, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.