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FDA 510(k)

Eneka Selectif

K-Number: K241656 · 2024-08-12

ApplicantTermosalud
Decision Date2024-08-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Eneka Selectif is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241656. 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 Eneka Selectif?

Eneka Selectif is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Termosalud. The 510(k) number is K241656.

When did Eneka Selectif receive FDA 510(k) clearance?

Eneka Selectif received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241656.

Who is the listed applicant for Eneka Selectif?

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

What is the FDA product code for Eneka Selectif?

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

Other records listing Termosalud 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.

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Related Devices (Code: GEX)

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.

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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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