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FDA 510(k)

Anchor Bolt (as an accessory to Depth Electrodes)

K-Number: K181544 · 2018-08-09

ApplicantAd-Tech Medical Instrument Corporation
Decision Date2018-08-09
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Anchor Bolt (as an accessory to Depth Electrodes) is a medical device manufactured by Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2018-08-09 under approval number K181544. 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 Anchor Bolt (as an accessory to Depth Electrodes)?

Anchor Bolt (as an accessory to Depth Electrodes) is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Ad-Tech Medical Instrument Corporation. The 510(k) number is K181544.

When was Anchor Bolt (as an accessory to Depth Electrodes) approved by the FDA?

Anchor Bolt (as an accessory to Depth Electrodes) received FDA 510(k) clearance on 2018-08-09, under approval number K181544.

What company makes Anchor Bolt (as an accessory to Depth Electrodes)?

Anchor Bolt (as an accessory to Depth Electrodes) is manufactured by Ad-Tech Medical Instrument Corporation.

What is the FDA product code for Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA product code for Anchor Bolt (as an accessory to 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 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

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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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