Discovery Pico Family
K-Number: K163222 · 2016-12-05
ApplicantQuanta System Spa
Decision Date2016-12-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Discovery Pico Family is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2016-12-05 under approval number K163222. 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 Discovery Pico Family?
Discovery Pico Family is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Quanta System Spa. The 510(k) number is K163222.
When was Discovery Pico Family approved by the FDA?
Discovery Pico Family received FDA 510(k) clearance on 2016-12-05, under approval number K163222.
What company makes Discovery Pico Family?
Discovery Pico Family is manufactured by Quanta System Spa.
What is the FDA product code for Discovery Pico Family?
The FDA product code for Discovery Pico Family 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.