Vydence Zye and Vydence One
K-Number: K202998 · 2021-10-26
Decision Date2021-10-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Vydence Zye and Vydence One is a medical device manufactured by Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2021-10-26 under approval number K202998. 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 Vydence Zye and Vydence One?
Vydence Zye and Vydence One is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by Vydence Medical Industria E Comercio Ltda. The 510(k) number is K202998.
When was Vydence Zye and Vydence One approved by the FDA?
Vydence Zye and Vydence One received FDA 510(k) clearance on 2021-10-26, under approval number K202998.
What company makes Vydence Zye and Vydence One?
Vydence Zye and Vydence One is manufactured by Vydence Medical Industria E Comercio Ltda.
What is the FDA product code for Vydence Zye and Vydence One?
The FDA product code for Vydence Zye and Vydence One 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.