FDA product code ODE: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ODE is the FDA product code for endoscopic suture/plication system, gastroesophageal reflux disease (gerd). It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 20 510(k) submissions under ODE, 2 in the last five years, from 5 different applicants. The average 510(k) review took 86 days (median 64); 148 days on average over the last three years. FDA has posted 4 recalls for ODE devices, 2 initiated in the last five years.
Definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ODE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 40 |
| 2024 | 2 | 148 |
Compare with all 510(k) review times · Search every ODE clearance
Top ODE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endogastric Solutions, Inc. | 8 | 2024-04-26 |
| Ndo Surgical, Inc. | 5 | 2007-10-18 |
| Medigus , Ltd. | 4 | 2015-06-05 |
| C.R. Bard, Inc. | 2 | 2001-01-05 |
| G-Surg GmbH | 1 | 2024-06-21 |
Most recent ODE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233240 | G-Surg GmbH | GERDX-System | 2024-06-21 | 267 |
| K240879 | Endogastric Solutions, Inc. | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | 2024-04-26 | 28 |
| K172811 | Endogastric Solutions, Inc. | EsophyX Z, EsophyX2 HD | 2017-10-19 | 31 |
| K171307 | Endogastric Solutions, Inc. | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | 2017-06-22 | 50 |
| K160960 | Endogastric Solutions, Inc. | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | 2016-05-01 | 26 |
Recalls for ODE devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-03-14.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code ODE?
ODE is the FDA product code for endoscopic suture/plication system, gastroesophageal reflux disease (gerd). It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODE?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODE?
Across 20 cleared submissions the average was 86 days from receipt to decision (median 64).
Which companies have the most ODE clearances?
Endogastric Solutions, Inc. (8); Ndo Surgical, Inc. (5); Medigus , Ltd. (4); C.R. Bard, Inc. (2); G-Surg GmbH (1).
Have ODE devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code ODE
- Run a recall and safety report across every ODE manufacturer
- Watch product code ODE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times