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FDA 510(k)

Spencer Probe Depth Electrodes

K-Number: K223269 · 2023-05-18

ApplicantAd-Tech Medical Instrument Corporation
Decision Date2023-05-18
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spencer Probe Depth Electrodes is a medical device manufactured by Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2023-05-18 under approval number K223269. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spencer Probe Depth Electrodes?

Spencer Probe Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-05-18. It is manufactured by Ad-Tech Medical Instrument Corporation. The 510(k) number is K223269.

When was Spencer Probe Depth Electrodes approved by the FDA?

Spencer Probe Depth Electrodes received FDA 510(k) clearance on 2023-05-18, under approval number K223269.

What company makes Spencer Probe Depth Electrodes?

Spencer Probe Depth Electrodes is manufactured by Ad-Tech Medical Instrument Corporation.

What is the FDA product code for Spencer Probe Depth Electrodes?

The FDA product code for Spencer Probe Depth Electrodes is GZL.

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Other Devices by Ad-Tech Medical Instrument Corporation

K152769FREMAP ELECTRODE K152547DNAP Electrode K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes K181544Anchor Bolt (as an accessory to Depth Electrodes) K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

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Related Devices (Code: GZL)

K151790PMT Platinum Depthalon Depth ElectrodePmt Corporation K152547DNAP ElectrodeAd-Tech Medical Instrument Corporation K171581Neuro Omega SystemAlpha Omega Engineering , Ltd. K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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