Smartxide Tetra Pro
K-Number: K240497 · 2024-03-12
ApplicantEl.En S.P.A.
Decision Date2024-03-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Smartxide Tetra Pro is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2024-03-12 under approval number K240497. 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 Smartxide Tetra Pro?
Smartxide Tetra Pro is a medical device that received FDA 510(k) clearance on 2024-03-12. It is manufactured by El.En S.P.A.. The 510(k) number is K240497.
When was Smartxide Tetra Pro approved by the FDA?
Smartxide Tetra Pro received FDA 510(k) clearance on 2024-03-12, under approval number K240497.
What company makes Smartxide Tetra Pro?
Smartxide Tetra Pro is manufactured by El.En S.P.A..
What is the FDA product code for Smartxide Tetra Pro?
The FDA product code for Smartxide Tetra Pro is GEX. This falls under the Gastroenterology category.
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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.