Venacure 1470 Pro
K-Number: K181632 · 2018-09-17
ApplicantQuanta System Spa
Decision Date2018-09-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Venacure 1470 Pro is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2018-09-17 under approval number K181632. 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 Venacure 1470 Pro?
Venacure 1470 Pro is a medical device that received FDA 510(k) clearance on 2018-09-17. It is manufactured by Quanta System Spa. The 510(k) number is K181632.
When was Venacure 1470 Pro approved by the FDA?
Venacure 1470 Pro received FDA 510(k) clearance on 2018-09-17, under approval number K181632.
What company makes Venacure 1470 Pro?
Venacure 1470 Pro is manufactured by Quanta System Spa.
What is the FDA product code for Venacure 1470 Pro?
The FDA product code for Venacure 1470 Pro 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.