Eneka Selectif
K-Number: K241656 · 2024-08-12
ApplicantTermosalud
Decision Date2024-08-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Eneka Selectif is a medical device manufactured by Termosalud. It received FDA 510(k) clearance on 2024-08-12 under approval 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. It is manufactured by Termosalud. The 510(k) number is K241656.
When was Eneka Selectif approved by the FDA?
Eneka Selectif received FDA 510(k) clearance on 2024-08-12, under approval number K241656.
What company makes Eneka Selectif?
Eneka Selectif is manufactured by Termosalud.
What is the FDA product code for Eneka Selectif?
The FDA product code for Eneka Selectif 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.