FDA 510(k)

400um Perforator and Accessory Vein Ablation Kit

K-Number: K181044 · 2018-07-05

Decision Date2018-07-05

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

400um Perforator and Accessory Vein Ablation 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 2018-07-05 under 510(k) number K181044. 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 400um Perforator and Accessory Vein Ablation Kit?

400um Perforator and Accessory Vein Ablation Kit is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K181044.

When did 400um Perforator and Accessory Vein Ablation Kit receive FDA 510(k) clearance?

400um Perforator and Accessory Vein Ablation Kit received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181044.

Who is the listed applicant for 400um Perforator and Accessory Vein Ablation 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 400um Perforator and Accessory Vein Ablation Kit?

The FDA product code for 400um Perforator and Accessory Vein Ablation 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.