510(k) clearance

Gastric Alimetry

FDA 510(k) source

510(k) number

K262292

Applicant

Alimetry , Ltd.

Decision date

Sep 4, 2026

Date received

Jul 7, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MYE

Device type

System, Electrogastrography (Egg)

Device class

Class II

Regulation

21 CFR 876.1735

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Auckland, NZ