MYE · Class II · 21 CFR 876.1735

FDA Product Code MYE: System, Electrogastrography (egg)

Leading manufacturers include Alimetry , Ltd. and G-Tech Medical.

8
Total
7
Cleared
136d
Avg days
1999
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 119d avg (recent)

FDA 510(k) Cleared System, Electrogastrography (egg) Devices (Product Code MYE)

8 devices
1–8 of 8
Cleared Dec 05, 2025
Gastric Alimetry
K252504
Alimetry , Ltd.
Gastroenterology & Urology · 119d
Cleared Jul 03, 2024
Gastric Alimetry
K240946
Alimetry , Ltd.
Gastroenterology & Urology · 89d
Cleared Nov 17, 2023
Gastric Alimetry System
K232925
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Apr 27, 2023
Gastric Alimetry System
K223398
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Jun 03, 2022
Gastric Alimetry System
K213924
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Jan 10, 2022
G-Tech Wireless Patch System (WPS)
K212954
G-Tech Medical
Gastroenterology & Urology · 116d

About Product Code MYE - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code MYE since 1999, with 7 receiving FDA clearance (average review time: 136 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - MYE Product Code

FDA review times for MYE submissions have been consistent, averaging 119 days recently vs 139 days historically.

MYE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →