FDA 510(k)

Gabriel Feeding Tube with Balloon, and EnFit Connector

Número K: K191784 · 2019-11-15

RequerenteSyncro Medical Innovations, Inc.

Data da decisão2019-11-15

Código do produtoPIF

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Gabriel Feeding Tube with Balloon, and EnFit Connector 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 2019-11-15 under 510(k) number K191784. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Gabriel Feeding Tube with Balloon, and EnFit Connector?

Gabriel Feeding Tube with Balloon, and EnFit Connector is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K191784.

When did Gabriel Feeding Tube with Balloon, and EnFit Connector receive FDA 510(k) clearance?

Gabriel Feeding Tube with Balloon, and EnFit Connector received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191784.

Who is the listed applicant for Gabriel Feeding Tube with Balloon, and EnFit Connector?

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, and EnFit Connector?

The FDA product code for Gabriel Feeding Tube with Balloon, and EnFit Connector is PIF.

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Outros registros que listam Syncro Medical Innovations, Inc. como candidato(a)

K201741Gabriel 3 Way EnFit Valve K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

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Fonte oficial

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