FDA product code MYE: System, Electrogastrography (Egg)
MYE is the FDA product code for system, electrogastrography (egg). It is a Class II device, regulated under 21 CFR 876.1735 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under MYE, 7 in the last five years, from 3 different applicants. The average 510(k) review took 139 days (median 118); 89 days on average over the last three years. 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | System, Electrogastrography (Egg) |
| Device class | Class II |
| Regulation | 21 CFR 876.1735 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for MYE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 143 |
| 2023 | 2 | 114 |
| 2024 | 1 | 89 |
| 2025 | 1 | 119 |
| 2026 | 1 | 59 |
Compare with all 510(k) review times · Search every MYE clearance
Top MYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alimetry , Ltd. | 6 | 2026-09-04 |
| G-Tech Medical | 1 | 2022-01-10 |
| Medtronic Functional Diagnostics A/S | 1 | 2002-11-21 |
Most recent MYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262292 | Alimetry , Ltd. | Gastric Alimetry | 2026-09-04 | 59 |
| K252504 | Alimetry , Ltd. | Gastric Alimetry | 2025-12-05 | 119 |
| K240946 | Alimetry , Ltd. | Gastric Alimetry | 2024-07-03 | 89 |
| K232925 | Alimetry , Ltd. | Gastric Alimetry System | 2023-11-17 | 59 |
| K223398 | Alimetry , Ltd. | Gastric Alimetry System | 2023-04-27 | 170 |
Recalls for MYE devices
openFDA lists no recalls for product code MYE.
Frequently asked questions
What is FDA product code MYE?
MYE is the FDA product code for system, electrogastrography (egg). It is a Class II device, regulated under 21 CFR 876.1735 and reviewed by the Gastroenterology and Urology panel.
What device class is MYE?
Class II, regulation 21 CFR 876.1735. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYE?
Across 8 cleared submissions the average was 139 days from receipt to decision (median 118).
Which companies have the most MYE clearances?
Alimetry , Ltd. (6); G-Tech Medical (1); Medtronic Functional Diagnostics A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYE
- Run a recall and safety report across every MYE manufacturer
- Watch product code MYE 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.
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