Gastric Alimetry— 510(k) K262292

Name: FDA 510(k) clearance K262292
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Alimetry , Ltd.

FDA 510(k) clearance K262292 for Gastric Alimetry, Substantially Equivalent on 2026-09-04. Applicant: Alimetry , Ltd.. Device class: 2.

Summary

Gastric Alimetry from Alimetry is filed under MYE, electrogastrography (EGG) systems. The record doesn't describe its components or outputs beyond that code name.

Class II, 21 CFR 876.1735. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Alimetry filed from Auckland, New Zealand. Review took 59 calendar days (July 7 to September 4, 2026).

Clearance details

Applicant: Alimetry , Ltd.
Product code: Product code MYE
Device class: Class 2
Regulation: 21 CFR 876.1735
Advisory panel: Gastroenterology, Urology
Date received: 2026-07-07
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.