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 C.R. Bard, Inc., G-Surg GmbH and Endogastric Solutions, Inc..
20
Total
20
Cleared
86d
Avg days
2000
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) Devices (Product Code ODE)
20 devices
Cleared
Jun 21, 2024
GERDX-System
G-Surg GmbH
Gastroenterology & Urology
267d
Cleared
Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Endogastric Solutions, Inc.
Gastroenterology & Urology
28d
Cleared
Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
C.R. Bard, Inc.
Gastroenterology & Urology
15d
Cleared
Mar 20, 2000
BARD ENDOSCOPIC SUTURING SYSTEM
C.R. Bard, Inc.
Gastroenterology & Urology
90d
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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.