Product code
ODE: Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | ODE |
|---|---|
| Device | Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) |
| Device class | Class II |
| Regulation number | 876.1500 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database