ODE

Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Product code

ODE

Device name

Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

20 (all years; only the last 3 years are listed here)

FDA classification definition

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-06-21.

2 summaries are archived here for direct download.