Gastric Alimetry

FDA 510(k) K262292 · Alimetry , Ltd.

Substantially Equivalent

510(k) numberK262292

Submission

Device name
Gastric Alimetry
Applicant
Alimetry , Ltd.
Auckland, NZ
Received
July 7, 2026
Decision date
September 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYE – System, Electrogastrography (Egg)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1735
Specialty
Gastroenterology, Urology

Other 510(k)s with product code MYE

510(k)DeviceApplicantDecision
K252504Gastric AlimetryMYE · Traditional Alimetry , Ltd.12/05/2025SE
K240946Gastric AlimetryMYE · Traditional Alimetry , Ltd.07/03/2024SE
K232925Gastric Alimetry SystemMYE · Traditional Alimetry , Ltd.11/17/2023SE
K223398Gastric Alimetry SystemMYE · Traditional Alimetry , Ltd.04/27/2023SE
K213924Gastric Alimetry SystemMYE · Traditional Alimetry , Ltd.06/03/2022SE
K212954G-Tech Wireless Patch System (WPS)MYE · Traditional G-Tech Medical01/10/2022SE
K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional Medtronic Functional Diagnostics A/S11/21/2002SE

More from Medtronic Functional Diagnostics A/S

510(k)DeviceDecision
K252504Gastric AlimetryMYE · Traditional 12/05/2025SE
K240946Gastric AlimetryMYE · Traditional 07/03/2024SE
K232925Gastric Alimetry SystemMYE · Traditional 11/17/2023SE
K223398Gastric Alimetry SystemMYE · Traditional 04/27/2023SE
K213924Gastric Alimetry SystemMYE · Traditional 06/03/2022SE

Questions and answers

When was Gastric Alimetry cleared by the FDA?

Gastric Alimetry (K262292) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 59 days after the submission was received.

What is the product code of K262292?

The FDA product code is MYE – System, Electrogastrography (Egg), a Class II (moderate risk) device regulated under 21 CFR 876.1735.