Deka Bluebeam
K-Number: K243683 · 2025-06-12
ApplicantEl.En S.P.A.
Decision Date2025-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Deka Bluebeam is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2025-06-12 under approval number K243683. 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 Bluebeam?
Deka Bluebeam is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by El.En S.P.A.. The 510(k) number is K243683.
When was Deka Bluebeam approved by the FDA?
Deka Bluebeam received FDA 510(k) clearance on 2025-06-12, under approval number K243683.
What company makes Deka Bluebeam?
Deka Bluebeam is manufactured by El.En S.P.A..
What is the FDA product code for Deka Bluebeam?
The FDA product code for Deka Bluebeam 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.