FDA 510(k)

AdvaTx

K-Number: K250189 · 2025-04-01

Decision Date2025-04-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AdvaTx is a medical device manufactured by Advalight Aps. It received FDA 510(k) clearance on 2025-04-01 under approval number K250189. 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 AdvaTx?

AdvaTx is a medical device that received FDA 510(k) clearance on 2025-04-01. It is manufactured by Advalight Aps. The 510(k) number is K250189.

When was AdvaTx approved by the FDA?

AdvaTx received FDA 510(k) clearance on 2025-04-01, under approval number K250189.

What company makes AdvaTx?

AdvaTx is manufactured by Advalight Aps.

What is the FDA product code for AdvaTx?

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

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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.