510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162459Substantially Equivalent

AccuPoint Electrode

Microprobes for Life Science, Inc. dba Neuron, Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162459 is the FDA 510(k) clearance record for AccuPoint Electrode, a class II device, cleared for Microprobes For Life Science, Inc. Dba Neuron on under FDA product code GZL (Electrode, Depth). FDA records list one 510(k) clearance for Microprobes For Life Science, Inc. Dba Neuron. As of , FDA records show no recalls naming K162459.

Clearance record

Decision date
Received
(286 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Microprobes For Life Science, Inc. Dba Neuron 18247-D Flower Hill Way, Gaithersburg MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260