FDA Product Code MYE: System, Electrogastrography (egg)
Leading manufacturers include Alimetry , Ltd., 3pm Co., Inc. and Medtronic Functional Diagnostics A/S.
9
Total
8
Cleared
128d
Avg days
1999
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
89d
recently vs 139d historically
FDA 510(k) Cleared System, Electrogastrography (egg) Devices (Product Code MYE)
9 devices
Cleared
Sep 04, 2026
Gastric Alimetry
Alimetry , Ltd.
Gastroenterology & Urology
59d
Cleared
Dec 05, 2025
Gastric Alimetry
Alimetry , Ltd.
Gastroenterology & Urology
119d
Cleared
Jul 03, 2024
Gastric Alimetry
Alimetry , Ltd.
Gastroenterology & Urology
89d
Cleared
Nov 17, 2023
Gastric Alimetry System
Alimetry , Ltd.
Gastroenterology & Urology
59d
Cleared
Apr 27, 2023
Gastric Alimetry System
Alimetry , Ltd.
Gastroenterology & Urology
170d
Cleared
Jun 03, 2022
Gastric Alimetry System
Alimetry , Ltd.
Gastroenterology & Urology
170d
Cleared
Jan 10, 2022
G-Tech Wireless Patch System (WPS)
G-Tech Medical
Gastroenterology & Urology
116d
Cleared
Nov 21, 2002
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology
329d
Not Cleared
Aug 20, 1999
THE 3PM EGG MACHINE
3pm Co., Inc.
Gastroenterology & Urology
39d
About Product Code MYE - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code MYE since 1999, with 8 receiving FDA clearance (average review time: 128 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - MYE Product Code
Recent submissions under MYE have taken an average of 89 days to reach a decision - down from 139 days historically, suggesting improved FDA processing for this classification.
MYE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →