Gastric Alimetry— 510(k) K262292

Substantially Equivalent

Alimetry , Ltd.

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

Clearance details

Applicant: Alimetry , Ltd.
Product code: 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 ↗

Recent devices under product code MYE

K252504 — Gastric Alimetry2025-12-05
K240946 — Gastric Alimetry2024-07-03
K232925 — Gastric Alimetry System2023-11-17
K223398 — Gastric Alimetry System2023-04-27
K213924 — Gastric Alimetry System2022-06-03

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