Gastric Alimetry— 510(k) K252504

Substantially Equivalent

Alimetry , Ltd.

FDA 510(k) clearance K252504 for Gastric Alimetry, Substantially Equivalent on 2025-12-05. 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: 2025-08-08
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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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.