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FDA 510(k)

Gastric Alimetry

K-Number: K252504 · 2025-12-05

ApplicantAlimetry , Ltd.
Decision Date2025-12-05
Product CodeMYE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gastric Alimetry is a medical device manufactured by Alimetry , Ltd.. It received FDA 510(k) clearance on 2025-12-05 under approval number K252504. The device is classified under product code MYE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gastric Alimetry?

Gastric Alimetry is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Alimetry , Ltd.. The 510(k) number is K252504.

When was Gastric Alimetry approved by the FDA?

Gastric Alimetry received FDA 510(k) clearance on 2025-12-05, under approval number K252504.

What company makes Gastric Alimetry?

Gastric Alimetry is manufactured by Alimetry , Ltd..

What is the FDA product code for Gastric Alimetry?

The FDA product code for Gastric Alimetry is MYE.

Related Clinical Trials

NCT05812339 Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls ENROLLING_BY_INVITATION

Other Devices by Alimetry , Ltd.

K213924Gastric Alimetry System K232925Gastric Alimetry System K223398Gastric Alimetry System K240946Gastric Alimetry

Related Devices (Code: MYE)

K213924Gastric Alimetry SystemAlimetry , Ltd. K212954G-Tech Wireless Patch System (WPS)G-Tech Medical K232925Gastric Alimetry SystemAlimetry , Ltd. K223398Gastric Alimetry SystemAlimetry , Ltd. K240946Gastric AlimetryAlimetry , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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