FRAXIS DUO
K-Number: K160312 · 2016-10-28
ApplicantIlooda Co,., Ltd.
Decision Date2016-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FRAXIS DUO is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2016-10-28 under approval number K160312. 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 FRAXIS DUO?
FRAXIS DUO is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K160312.
When was FRAXIS DUO approved by the FDA?
FRAXIS DUO received FDA 510(k) clearance on 2016-10-28, under approval number K160312.
What company makes FRAXIS DUO?
FRAXIS DUO is manufactured by Ilooda Co,., Ltd..
What is the FDA product code for FRAXIS DUO?
The FDA product code for FRAXIS DUO 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.