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FDA 510(k)

ANGIODYNAMICS, INC. VENACURE 1470 LASER

K-Number: K110225 · 2011-05-13

ApplicantAngioDynamics, Inc.
Decision Date2011-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS, INC. VENACURE 1470 LASER is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K110225. 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 1470 LASER?

ANGIODYNAMICS, INC. VENACURE 1470 LASER is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K110225.

When did ANGIODYNAMICS, INC. VENACURE 1470 LASER receive FDA 510(k) clearance?

ANGIODYNAMICS, INC. VENACURE 1470 LASER received FDA 510(k) clearance on 2011-05-13, under 510(k) number K110225.

Who is the listed applicant for ANGIODYNAMICS, INC. VENACURE 1470 LASER?

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 1470 LASER?

The FDA product code for ANGIODYNAMICS, INC. VENACURE 1470 LASER 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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