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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2024-03-12 under 510(k) 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. The listed applicant is El.En S.P.A.. The 510(k) number is K240497.

When did Smartxide Tetra Pro receive FDA 510(k) clearance?

Smartxide Tetra Pro received FDA 510(k) clearance on 2024-03-12, under 510(k) number K240497.

Who is the listed applicant for Smartxide Tetra Pro?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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.

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