MYEClass II
System, Electrogastrography (Egg)
21 CFR 876.1735 / Gastroenterology, Urology
MYE is the FDA product code for System, Electrogastrography (Egg), a class II device type, regulated under 21 CFR 876.1735. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- MYE
- Device name
- System, Electrogastrography (Egg)
- Regulation
- 21 CFR 876.1735
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 0
Clearances, product code MYE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2002 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code MYE| Applicant | Clearances |
|---|---|
| Alimetry Ltd | 5 |
| 3pm Co., Inc. | 1 |
| Alimetry , Ltd. | 1 |
| G-TECH MEDICAL Inc. | 1 |
| Medtronic Functional Diagnostics A/S | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
