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510(k) K162459

AccuPoint Electrode by Microprobes For Life Science, Inc. Dba Neuron — Product Code GZL

K162459 is an FDA 510(k) premarket notification submitted by Microprobes For Life Science, Inc. Dba Neuron for the device "AccuPoint Electrode". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
September 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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FDA data resources