FDA 510(k)

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT

K-Number: K112600 · 2012-01-30

Decision Date2012-01-30

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT 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 2012-01-30 under 510(k) number K112600. 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 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT?

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2012-01-30. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K112600.

When did ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT receive FDA 510(k) clearance?

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT received FDA 510(k) clearance on 2012-01-30, under 510(k) number K112600.

Who is the listed applicant for ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT 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 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT?

The FDA product code for ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT is GEX. This falls under the Gastroenterology category.

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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.