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FDA 510(k)

VENX REVOLUTION

K-Number: K110355 · 2011-04-22

ApplicantVenx, LLC
Decision Date2011-04-22
Product CodeGAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENX REVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Venx, LLC. It received FDA 510(k) clearance on 2011-04-22 under 510(k) number K110355. The device is classified under product code GAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENX REVOLUTION?

VENX REVOLUTION is a medical device that received FDA 510(k) clearance on 2011-04-22. The listed applicant is Venx, LLC. The 510(k) number is K110355.

When did VENX REVOLUTION receive FDA 510(k) clearance?

VENX REVOLUTION received FDA 510(k) clearance on 2011-04-22, under 510(k) number K110355.

Who is the listed applicant for VENX REVOLUTION?

The FDA 510(k) record lists Venx, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENX REVOLUTION?

The FDA product code for VENX REVOLUTION is GAH.

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Related Devices (Code: GAH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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