DEKA AGAIN PRO family
K-Number: K233090 · 2023-10-27
ApplicantEl.En S.P.A.
Decision Date2023-10-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEKA AGAIN PRO family is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2023-10-27 under approval number K233090. 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 DEKA AGAIN PRO family?
DEKA AGAIN PRO family is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by El.En S.P.A.. The 510(k) number is K233090.
When was DEKA AGAIN PRO family approved by the FDA?
DEKA AGAIN PRO family received FDA 510(k) clearance on 2023-10-27, under approval number K233090.
What company makes DEKA AGAIN PRO family?
DEKA AGAIN PRO family is manufactured by El.En S.P.A..
What is the FDA product code for DEKA AGAIN PRO family?
The FDA product code for DEKA AGAIN PRO family 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.