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FDA 510(k)

MEDIDIODE

K-Number: K231950 · 2024-08-09

ApplicantMedicreations, LLC
Decision Date2024-08-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDIDIODE is the device name listed in this FDA 510(k) record. The listed applicant is Medicreations, LLC. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K231950. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIDIODE?

MEDIDIODE is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Medicreations, LLC. The 510(k) number is K231950.

When did MEDIDIODE receive FDA 510(k) clearance?

MEDIDIODE received FDA 510(k) clearance on 2024-08-09, under 510(k) number K231950.

Who is the listed applicant for MEDIDIODE?

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

What is the FDA product code for MEDIDIODE?

The FDA product code for MEDIDIODE is GEX. This falls under the Gastroenterology category.

Other records listing Medicreations, LLC 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.

K231952MEDILIGHTK231948MEDIYAG

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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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