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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-04-06 under 510(k) 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. The listed applicant is Formatk Systems , Ltd.. The 510(k) number is K153566.

When did Magma System receive FDA 510(k) clearance?

Magma System received FDA 510(k) clearance on 2016-04-06, under 510(k) number K153566.

Who is the listed applicant for Magma System?

The FDA 510(k) record lists Formatk Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magma System?

The FDA product code for Magma System is GEX. This falls under the Gastroenterology category.

Other records listing Formatk Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183307Magma Spark Pro (Magma Spark Plus, Alpha)K162781Magma SparkK160195Forma System, Forma Light System

Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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