FDA 510(k)

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

Número K: K160787 · 2016-08-09

RequerenteSyncro Medical Innovations, Inc.

Data da decisão2016-08-09

Código do produtoKNT

Comité consultivoGU

DecisãoUnknown

Resumo do 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.

Perguntas frequentes

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.

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Fonte oficial

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