DEKA HELIX
K-Number: K222221 · 2023-01-04
ApplicantEl.En Electronic Engineering Spa
Decision Date2023-01-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEKA HELIX is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2023-01-04 under approval number K222221. 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 HELIX?
DEKA HELIX is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K222221.
When was DEKA HELIX approved by the FDA?
DEKA HELIX received FDA 510(k) clearance on 2023-01-04, under approval number K222221.
What company makes DEKA HELIX?
DEKA HELIX is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for DEKA HELIX?
The FDA product code for DEKA HELIX 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.