FDA 510(k) Applications Submitted by SYNCRO MEDICAL INNOVATIONS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K160787 03/22/2016 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet SYNCRO MEDICAL INNOVATIONS, INC.
K201741 06/25/2020 Gabriel 3 Way EnFit Valve Syncro Medical Innovations, Inc.
K191784 07/03/2019 Gabriel Feeding Tube with Balloon, and EnFit Connector Syncro Medical Innovations, Inc.
K021991 06/18/2002 MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE SYNCRO MEDICAL INNOVATIONS, INC.
K072787 10/01/2007 GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 SYNCRO MEDICAL INNOVATIONS, INC.
K110005 01/03/2011 SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE SYNCRO MEDICAL INNOVATIONS, INC.


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