V20 system
K-Number: K152611 · 2016-02-19
ApplicantViora , Ltd.
Decision Date2016-02-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
V20 system is a medical device manufactured by Viora , Ltd.. It received FDA 510(k) clearance on 2016-02-19 under approval number K152611. 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 V20 system?
V20 system is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Viora , Ltd.. The 510(k) number is K152611.
When was V20 system approved by the FDA?
V20 system received FDA 510(k) clearance on 2016-02-19, under approval number K152611.
What company makes V20 system?
V20 system is manufactured by Viora , Ltd..
What is the FDA product code for V20 system?
The FDA product code for V20 system 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.