GFX Nerve Ablation System

FDA 510(k) K063753 · Aci, Inc.

Substantially Equivalent

510(k) numberK063753

Submission

Device name
GFX Nerve Ablation System
Applicant
Aci, Inc.
Lakewood, CO, US
Received
December 19, 2006
Decision date
June 20, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was GFX Nerve Ablation System cleared by the FDA?

GFX Nerve Ablation System (K063753) received a 510(k) decision of Substantially Equivalent on June 20, 2007, 183 days after the submission was received.

What is the product code of K063753?

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