510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201678Substantially Equivalent

iCE-SG Subcutaneous Electrode Arrays

Ice Neurosystems, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201678 is the FDA 510(k) clearance record for iCE-SG Subcutaneous Electrode Arrays, a class II device, cleared for Ice Neurosystems, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 3 510(k) clearances for Ice Neurosystems, Inc., from to . As of , FDA records show no recalls naming K201678.

Clearance record

Decision date
Received
(262 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Ice Neurosystems, Inc. 1875 Connecticut Ave. NW, Suite 12117, Washington DC
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