510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211367Substantially Equivalent

Evo sEEG System

Neuroone Medical Technologies Corp., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211367 is the FDA 510(k) clearance record for Evo sEEG System, a class II device, cleared for Neuroone Medical Technologies Corp. on under FDA product code GZL (Electrode, Depth). FDA records list 4 510(k) clearances for Neuroone Medical Technologies Corp., from to . As of , FDA records show no recalls naming K211367.

Clearance record

Decision date
Received
(120 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Neuroone Medical Technologies Corp. 7599 Anagram Dr., Eden Prairie MN
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