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FDA 510(k)

Venus Epileve

K-Number: K200786 · 2020-06-09

ApplicantVenus Concept USA, Inc.
Decision Date2020-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Epileve is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K200786. 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 Venus Epileve?

Venus Epileve is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K200786.

When did Venus Epileve receive FDA 510(k) clearance?

Venus Epileve received FDA 510(k) clearance on 2020-06-09, under 510(k) number K200786.

Who is the listed applicant for Venus Epileve?

The FDA 510(k) record lists Venus Concept USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venus Epileve?

The FDA product code for Venus Epileve is GEX. This falls under the Gastroenterology category.

Other records listing Venus Concept USA, Inc. as applicant

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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.

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