Magma Spark
K-Number: K162781 · 2016-11-09
ApplicantFormatk Systems , Ltd.
Decision Date2016-11-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Magma Spark is a medical device manufactured by Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-09 under approval number K162781. 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 Spark?
Magma Spark is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Formatk Systems , Ltd.. The 510(k) number is K162781.
When was Magma Spark approved by the FDA?
Magma Spark received FDA 510(k) clearance on 2016-11-09, under approval number K162781.
What company makes Magma Spark?
Magma Spark is manufactured by Formatk Systems , Ltd..
What is the FDA product code for Magma Spark?
The FDA product code for Magma Spark 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.