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FDA 510(k)

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

K-Number: K163355 · 2017-04-12

ApplicantAd-Tech Medical Instrument Corporation
Decision Date2017-04-12
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is a medical device manufactured by Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-04-12 under approval number K163355. 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 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is a medical device that received FDA 510(k) clearance on 2017-04-12. It is manufactured by Ad-Tech Medical Instrument Corporation. The 510(k) number is K163355.

When was Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes approved by the FDA?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes received FDA 510(k) clearance on 2017-04-12, under approval number K163355.

What company makes Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is manufactured by Ad-Tech Medical Instrument Corporation.

What is the FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

The FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, 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 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 K223276Anchor Bolts as Accessories to Depth Electrodes

View all 8 devices →

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 K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc.

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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