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FDA 510(k)

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

N.º K: K160787 · 2016-08-09

SolicitanteSyncro Medical Innovations, Inc.
Fecha de decisión2016-08-09
Código de productoKNT
Comité asesorGU
DecisiónUnknown

Resumen del dispositivo

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K160787. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K160787.

When did Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet receive FDA 510(k) clearance?

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet received FDA 510(k) clearance on 2016-08-09, under 510(k) number K160787.

Who is the listed applicant for Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

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

What is the FDA product code for Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

The FDA product code for Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is KNT.

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.

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Otros registros que enlistan a Syncro Medical Innovations, Inc. como solicitante

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.

K201741Gabriel 3 Way EnFit ValveK191784Gabriel Feeding Tube with Balloon, and EnFit Connector

Dispositivos relacionados (Código: KNT)

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.

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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.

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