Gastric Alimetry System

FDA 510(k) K213924 · Alimetry , Ltd.

Substantially Equivalent

510(k) numberK213924

Submission

Device name
Gastric Alimetry System
Applicant
Alimetry , Ltd.
Grafton, NZ
Received
December 15, 2021
Decision date
June 3, 2022
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
K262292Gastric AlimetryMYE · Traditional Alimetry , Ltd.09/04/2026SE
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
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
K262292Gastric AlimetryMYE · Traditional 09/04/2026SE
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

Questions and answers

When was Gastric Alimetry System cleared by the FDA?

Gastric Alimetry System (K213924) received a 510(k) decision of Substantially Equivalent on June 3, 2022, 170 days after the submission was received.

What is the product code of K213924?

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