MYE — System, Electrogastrography (Egg) Class II

FDA Device Classification

FDA product code MYE covers "System, Electrogastrography (Egg)", a Class II medical device regulated under 21 CFR 876.1735. Submissions are reviewed by the Gastroenterology, Urology panel. At least 9 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MYE
Device Class
Class II
Regulation Number
876.1735
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K262292alimetryGastric AlimetrySeptember 4, 2026
K252504alimetryGastric AlimetryDecember 5, 2025
K240946alimetryGastric AlimetryJuly 3, 2024
K232925alimetryGastric Alimetry SystemNovember 17, 2023
K223398alimetryGastric Alimetry SystemApril 27, 2023
K213924alimetryGastric Alimetry SystemJune 3, 2022
K212954g-tech medicalG-Tech Wireless Patch System (WPS)January 10, 2022
K014269medtronic functional diagnosticsPOLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAFNovember 21, 2002
DEN9900053pm coTHE 3PM EGG MACHINEAugust 20, 1999