AccuPoint Electrode

FDA 510(k) K162459 · Microprobes For Life Science, Inc. Dba Neuron

Substantially Equivalent

510(k) numberK162459

Submission

Device name
AccuPoint Electrode
Applicant
Microprobes For Life Science, Inc. Dba Neuron
Gaithersburg, MD, US
Received
September 2, 2016
Decision date
June 15, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

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Questions and answers

When was AccuPoint Electrode cleared by the FDA?

AccuPoint Electrode (K162459) received a 510(k) decision of Substantially Equivalent on June 15, 2017, 286 days after the submission was received.

What is the product code of K162459?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.