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FDA 510(k)

Gabriel Feeding Tube with Balloon, and EnFit Connector

K-Number: K191784 · 2019-11-15

ApplicantSyncro Medical Innovations, Inc.
Decision Date2019-11-15
Product CodePIF
Advisory CommitteeGU
DecisionUnknown

Device Summary

Gabriel Feeding Tube with Balloon, and EnFit Connector is a medical device manufactured by Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-15 under approval number K191784. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

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. It is manufactured by Syncro Medical Innovations, Inc.. The 510(k) number is K191784.

When was Gabriel Feeding Tube with Balloon, and EnFit Connector approved by the FDA?

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

What company makes Gabriel Feeding Tube with Balloon, and EnFit Connector?

Gabriel Feeding Tube with Balloon, and EnFit Connector is manufactured by Syncro Medical Innovations, Inc..

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.

Other Devices by Syncro Medical Innovations, Inc.

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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