FDA Product Code ODE: Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.
Leading manufacturers include G-Surg GmbH and Endogastric Solutions, Inc..
FDA 510(k) Cleared Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) Devices (Product Code ODE)
About Product Code ODE - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code ODE since 2000, with 20 receiving FDA clearance (average review time: 86 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under ODE have taken an average of 267 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.
ODE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →