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FDA 510(k)

VenaCure EVLT NeverTouch Procedure Kit

K-Number: K162914 · 2016-11-16

ApplicantAngioDynamics, Inc.
Decision Date2016-11-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VenaCure EVLT NeverTouch Procedure Kit is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K162914. 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 EVLT NeverTouch Procedure Kit?

VenaCure EVLT NeverTouch Procedure Kit is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K162914.

When did VenaCure EVLT NeverTouch Procedure Kit receive FDA 510(k) clearance?

VenaCure EVLT NeverTouch Procedure Kit received FDA 510(k) clearance on 2016-11-16, under 510(k) number K162914.

Who is the listed applicant for VenaCure EVLT NeverTouch Procedure Kit?

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

What is the FDA product code for VenaCure EVLT NeverTouch Procedure Kit?

The FDA product code for VenaCure EVLT NeverTouch Procedure Kit 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.

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