Product code GZL— Neurology
AD-TECH'S DEPTH ELECTRODE
- Classification name
- Electrode, Depth
- Device class
- Class 2
- Regulation
- 21 CFR 882.1330
- Advisory panel
- Neurology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code GZL
FDA has cleared devices under product code GZL between 1980 and 2026, filed by 28 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2023
- 2022
- 2021
- 2020
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
- 2009
- 2007
Top applicants under product code GZL
Recent clearances under product code GZL
- K253970 — Wovyn Depth Electrode
- K250363 — Depth Electrode (17+ models)
- K250601 — Neuro Omega System; NeuroSmart System
- K223269 — Spencer Probe Depth Electrodes
- K223276 — Anchor Bolts as Accessories to 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
- K802151 — PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
- K802152 — PMT DEPTHALON DEPTH #2102
- K802249 — MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
Data sourced from openFDA. This site is unofficial and independent of the FDA.