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FDA 510(k)

Gabriel 3 Way EnFit Valve

K-Number: K201741 · 2020-11-05

ApplicantSyncro Medical Innovations, Inc.
Decision Date2020-11-05
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gabriel 3 Way EnFit Valve is a medical device manufactured by Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2020-11-05 under approval number K201741. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gabriel 3 Way EnFit Valve?

Gabriel 3 Way EnFit Valve is a medical device that received FDA 510(k) clearance on 2020-11-05. It is manufactured by Syncro Medical Innovations, Inc.. The 510(k) number is K201741.

When was Gabriel 3 Way EnFit Valve approved by the FDA?

Gabriel 3 Way EnFit Valve received FDA 510(k) clearance on 2020-11-05, under approval number K201741.

What company makes Gabriel 3 Way EnFit Valve?

Gabriel 3 Way EnFit Valve is manufactured by Syncro Medical Innovations, Inc..

What is the FDA product code for Gabriel 3 Way EnFit Valve?

The FDA product code for Gabriel 3 Way EnFit Valve 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 K191784Gabriel Feeding Tube with Balloon, and EnFit Connector

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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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