Litho Evo
K-Number: K192990 · 2019-12-20
ApplicantQuanta System Spa
Decision Date2019-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Litho Evo is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2019-12-20 under approval number K192990. 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 Litho Evo?
Litho Evo is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Quanta System Spa. The 510(k) number is K192990.
When was Litho Evo approved by the FDA?
Litho Evo received FDA 510(k) clearance on 2019-12-20, under approval number K192990.
What company makes Litho Evo?
Litho Evo is manufactured by Quanta System Spa.
What is the FDA product code for Litho Evo?
The FDA product code for Litho Evo 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.