Magma System
K-Number: K153566 · 2016-04-06
ApplicantFormatk Systems , Ltd.
Decision Date2016-04-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Magma System is a medical device manufactured by Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-04-06 under approval number K153566. 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 Magma System?
Magma System is a medical device that received FDA 510(k) clearance on 2016-04-06. It is manufactured by Formatk Systems , Ltd.. The 510(k) number is K153566.
When was Magma System approved by the FDA?
Magma System received FDA 510(k) clearance on 2016-04-06, under approval number K153566.
What company makes Magma System?
Magma System is manufactured by Formatk Systems , Ltd..
What is the FDA product code for Magma System?
The FDA product code for Magma 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.