Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

United Urologics Closed System Catheter

N.º K: K160877 · 2016-05-20

SolicitanteRobling Medical, Inc.
Fecha de decisión2016-05-20
Código de productoKOD
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

United Urologics Closed System Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160877. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the United Urologics Closed System Catheter?

United Urologics Closed System Catheter is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Robling Medical, Inc.. The 510(k) number is K160877.

When did United Urologics Closed System Catheter receive FDA 510(k) clearance?

United Urologics Closed System Catheter received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160877.

Who is the listed applicant for United Urologics Closed System Catheter?

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

What is the FDA product code for United Urologics Closed System Catheter?

The FDA product code for United Urologics Closed System Catheter is KOD.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: KOD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑