Cleared Traditional

K041409 - MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

K041409 is an FDA 510(k) clearance for MICRO-RECORDING AND STIMULATION ELECTRO..., manufactured by Inomed GmbH. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K041409 · Inomed GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
85d
Days
Class 2
Risk

K041409 is an FDA 510(k) clearance for the MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230.... Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Inomed GmbH (Se-103 93 Stockholm, SE). The FDA issued a Cleared decision on August 20, 2004 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041409

510(k) Number K041409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2004
Decision Date August 20, 2004
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K041409.
NEURODRIVE SYSTEM
K051830 · Alpha Omega , Ltd. · Sep 2005
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K042384 · Cyberkinetics, Inc. (Cki) · Mar 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · Inomed Medizintechnik GmbH · Mar 2005
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp · Aug 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004
MICRO TARGETING ELECTRODE
K033173 · FHC, Inc. · Mar 2004
K041409 · MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
Download PDF FDA Summary Inomed GmbH