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FDA 510(k)

Vydence Zye and Vydence One

K-Number: K202998 · 2021-10-26

ApplicantVydence Medical Industria E Comercio Ltda
Decision Date2021-10-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vydence Zye and Vydence One is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2021-10-26 under 510(k) 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. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K202998.

When did Vydence Zye and Vydence One receive FDA 510(k) clearance?

Vydence Zye and Vydence One received FDA 510(k) clearance on 2021-10-26, under 510(k) number K202998.

Who is the listed applicant for Vydence Zye and Vydence One?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Vydence Medical Industria E Comercio Ltda as applicant

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Official Source

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