NT 2000 Lesioning Generator

FDA 510(k) K111576 · Neuro Therm, Inc.

Substantially Equivalent

510(k) numberK111576

Submission

Device name
NT 2000 Lesioning Generator
Applicant
Neuro Therm, Inc.
Ashland, MA, US
Received
June 6, 2011
Decision date
September 20, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXD – Generator, Lesion, Radiofrequency
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4400
Specialty
Neurology

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K181864Polaris RF Ablation SystemGXD · Traditional Baylis Medical Company, Inc.01/02/2019SE
K171143Relievant Medsystems RF GeneratorGXD · Traditional Relievant Medsystems08/18/2017SE

More from Relievant Medsystems

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Questions and answers

When was NT 2000 Lesioning Generator cleared by the FDA?

NT 2000 Lesioning Generator (K111576) received a 510(k) decision of Substantially Equivalent on September 20, 2011, 106 days after the submission was received.

What is the product code of K111576?

The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.