510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041409Substantially Equivalent

Micro-Recording and Stimulation Electrodes-Micro Macroelectrode Model No. 230700-230799

inomed Inc., Se-103 93 Stockholm, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041409 is the FDA 510(k) clearance record for MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799, a class II device, cleared for Inomed GmbH on under FDA product code GZL (Electrode, Depth). FDA records list one 510(k) clearance for Inomed GmbH. As of , FDA records show no recalls naming K041409.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Inomed GmbH Kungstensgatan 18, Po Bx 7593, Se-103 93 Stockholm, SE
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