BEUDAMED
    Product Code: GZL FDA class 2 21 CFR 882.1330

    Electrode, Depth

    Neurology

    The Depth Electrode is a multi-contact electrode designed for stereotactic implantation deep into brain tissue to record electrical activity from specific brain structures, most commonly used in the presurgical evaluation of patients with drug-resistant epilepsy. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZL under regulation 21 CFR 882.1330 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    58
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    28
    Years Active
    45

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    Basic Information

    Product Code
    GZL
    Device Class
    FDA class 2
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 58 510(k) clearances via K numbers.

    K Number Device Name
    K253970 Wovyn Depth Electrode
    K250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
    K250601 Neuro Omega System; NeuroSmart System
    K223276 Anchor Bolts as Accessories to Depth Electrodes
    K223269 Spencer Probe Depth Electrodes
    K213170 SENSOSEEG Depth Electrodes
    K222706 iCE-SG2 Subcutaneous Electrode Kit
    K222404 Evo® sEEG System
    K220553 Neuro Omega System, NeuroSmart System
    K202087 DIXI Medical Microdeep Micro-Macro Depth Electrodes
    K211367 Evo sEEG System
    K201678 iCE-SG Subcutaneous Electrode Arrays
    K191739 Sterile LeadConfirm
    K183123 microTargeting Guideline 4000 5.0 System
    K181544 Anchor Bolt (as an accessory to Depth Electrodes)
    K172042 NeuroNav System, NeuroSmart System
    K171581 Neuro Omega System
    K170959 DIXI Medical Microdeep Depth Electrode
    K162459 AccuPoint Electrode
    K163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
    K151790 PMT Platinum Depthalon Depth Electrode
    K152547 DNAP Electrode
    K140680 LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
    K123796 NEURO OMEGA SYSTEM
    K120098 STERILE DISPOSABLES FOR MER
    K110010 NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
    K082404 NAVIGATION PROBES
    K071697 NEURONAV SYSTEM AND NEURONAV DRIVE
    K070272 NEUROPORT ELECTRODE
    K071364 MICROTARGETING GUIDELINE 4000
    K053358 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
    K052527 NEUROPROBES
    K051830 NEURODRIVE SYSTEM
    K042384 NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
    K042208 ISIS MER SYSTEM/ELEKTA MER SYSTEM
    K041409 MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
    K041604 MACRO-MICRO DEPTH ELECTRODE
    K033730 PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
    K033173 MICRO TARGETING ELECTRODE
    K012850 RECORDING AND STIMULATING ELECTRODE
    K991522 MICROTARGETING ELECTRODE
    K993622 NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
    K990788 AD-TECH'S FORAMEN OVALE ELECTRODE
    K991077 MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
    K981820 NEUROMAP
    K981015 PALI-TRODE
    K973454 AD-TECH'S SPINAL ELECTRODE
    K970943 GUIDELINE SYSTEM
    K964644 AD-TECH'S DEPTH ELECTRODE
    K970418 PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
    K946018 TENS-IT, FITTRONIC II, (MORE LATER)
    K944061 CUEVA CRANIAL NERVE ELECTRODE
    K902976 MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
    K891920 AD-TECH'S DEPTH ELECTRODE
    K861031 WYLER SPHENOIDAL ELECTRODE
    K802249 MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
    K802152 PMT DEPTHALON DEPTH #2102
    K802151 PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.