Last synced on 25 November 2022 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160787
510(k) Type
Traditional
Applicant
SYNCRO MEDICAL INNOVATIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent - Kit with Drugs
Decision Date
8/9/2016
Days to Decision
140 days
Submission Type
Summary