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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 the device name listed in this FDA 510(k) record. The listed applicant is Alimetry , Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) 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. The listed applicant is Alimetry , Ltd.. The 510(k) number is K252504.

When did Gastric Alimetry receive FDA 510(k) clearance?

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

Who is the listed applicant for Gastric Alimetry?

The FDA 510(k) record lists Alimetry , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastric Alimetry?

The FDA product code for Gastric Alimetry is MYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05812339Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and ControlsENROLLING_BY_INVITATIONNCT06401746Body Surface Gastric Mapping in Patients on SemaglutideCOMPLETEDNCT06411574Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in GastroparesisCOMPLETEDNCT06854120Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment EffectsRECRUITINGNCT07632378The Effect of taVNS and Upper GI MotilityRECRUITING

Other records listing Alimetry , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240946Gastric AlimetryK232925Gastric Alimetry SystemK223398Gastric Alimetry SystemK213924Gastric Alimetry System

Related Devices (Code: MYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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

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